# GUANGZHOU SHANGSHI COSMETICS CO · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GUANGZHOU SHANGSHI COSMETICS CO · 89-08 · CHINA, 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 CHINA; product is OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT; product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 G - - EX Powered laser surgical instruments | 79 O - - AP laser, comb, hair | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - KJ Light based treatment for cold sores herpes simplex virus-1 | 79 O - - LI Fat Reducing Low Level Laser | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy | 95 R - - HL Laser therapy product; date published is 09/04/2024; address is No. 2 North Street , Baiyun District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** GUANGZHOU SHANGSHI COSMETICS CO _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** No. 2 North Street , Baiyun District , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 09/04/2024 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 G - - EX Powered laser surgical instruments | 79 O - - AP laser, comb, hair | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - KJ Light based treatment for cold sores herpes simplex virus-1 | 79 O - - LI Fat Reducing Low Level Laser | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy | 95 R - - HL Laser therapy product _(verified: each item appears in the quote below)_
- **Product:** OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT | OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT _(verified: each item appears in the quote below)_

## What the source says

> GUANGZHOU SHANGSHI COSMETICS CO Date Published : 09/04/2024 No. 2 North Street , Baiyun District , Guangzhou, Guangdong CHINA 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 79 G - - EX Powered laser surgical instruments Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 79 O - - AP laser, comb, hair Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 79 O - - KJ Light based treatment for cold sores herpes simplex virus-1 Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 79 O - - LI Fat Reducing Low Level Laser Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT 95 R - - HL Laser therapy product Date Published: 09/04/2024 Desc: OMEGA light Low Level LED Therapy BEAUTY INSTRUMENT

## 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/).