Vivida SA cc · 89-08 · SOUTH AFRICA
For Vivida SA cc, import alert is 89-08; country is SOUTH AFRICA; 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)"; 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 2026-09-30.
- Firm
- Vivida SA cc verified
- 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
- Address
- 183 Bree Street , Cape Town, Western Cape SOUTH AFRICA verified
- Date published
- 07/20/2012 verified
- 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 each item verified
- 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 each item verified
- 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. each item verified
What the source says
Vivida SA cc Date Published : 07/20/2012 183 Bree Street , Cape Town, Western Cape SOUTH AFRICA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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