# Vivida SA cc · 89-08 · SOUTH AFRICA — FDA import alert red lists: firms subject to detention without physical examination

For Vivida SA cc · 89-08 · SOUTH AFRICA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is SOUTH AFRICA; product is Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices; product code is 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FD Dermatome | 79 G - - FE Brush, Dermabrasion | 79 M - - DM Instrument, Manual, General Surgical | 79 N - - AB Gauze/Sponge, Nonresorbable For External Use | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat; date published is 07/20/2012; address is 183 Bree Street , Cape Town, Western Cape SOUTH AFRICA, verified against its source on 2026-09-16.

- **Firm:** Vivida SA cc _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** SOUTH AFRICA _(verified: appears in the quote below)_
- **Address:** 183 Bree Street , Cape Town, Western Cape SOUTH AFRICA _(verified: appears in the quote below)_
- **Date published:** 07/20/2012 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FD Dermatome | 79 G - - FE Brush, Dermabrasion | 79 M - - DM Instrument, Manual, General Surgical | 79 N - - AB Gauze/Sponge, Nonresorbable For External Use | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat _(verified: each item appears in the quote below)_
- **Product:** Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices | Dermabraders or demabrasion devices _(verified: each item appears in the quote below)_
- **FDA notes:** class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ; | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. | class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. _(verified: each item appears in the quote below)_

## What the source says

> Vivida SA cc Date Published : 07/20/2012 183 Bree Street , Cape Town, Western Cape SOUTH AFRICA 53 L - - 09 Skin Fresheners (Skin Care Preparations) Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 79 G - - ED Brush, Dermabrasion, Manual Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 79 G - - FD Dermatome Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 79 G - - FE Brush, Dermabrasion Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 79 M - - DM Instrument, Manual, General Surgical Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 79 N - - AB Gauze/Sponge, Nonresorbable For External Use Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. ; 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 07/20/2012 Desc: Dermabraders or demabrasion devices Notes: class I/II;Note; Common names of these types devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).