# Beijing ADSS Development Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Beijing ADSS Development Co., Ltd. · 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 PDT Machine | Beauty Machine | PDT Machine | Beauty Machine; product code is 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 79 O - - LP Over-the-counter powered red/blue light based laser for acne; date published is 02/01/2024; address is Southern Area , Fuda Road - Tongsheng Road , Langfang, Hebei CHINA, verified against its source on 2026-09-16.

- **Firm:** Beijing ADSS Development Co., Ltd. _(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:** Southern Area , Fuda Road - Tongsheng Road , Langfang, Hebei CHINA _(verified: appears in the quote below)_
- **Date published:** 02/01/2024 _(verified: appears in the quote below)_
- **Product code:** 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - LP Over-the-counter powered red/blue light based laser for acne | 79 O - - LP Over-the-counter powered red/blue light based laser for acne _(verified: each item appears in the quote below)_
- **Product:** PDT Machine | Beauty Machine | PDT Machine | Beauty Machine _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II ; | Class II | Class II ; | Class II ; | Class II | Class II | Class II _(also on this page, in the second passage quoted below)_

## What the source says

> Beijing ADSS Development Co., Ltd. Date Published : 02/01/2024 Southern Area , Fuda Road - Tongsheng Road , Langfang, Hebei CHINA 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 02/01/2024 Desc: PDT Machine 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 02/01/2024 Desc: Beauty Machine 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 02/01/2024 Desc: PDT Machine 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 02/01/2024 Desc: Beauty Machine

## The same source also states

> Beijing ADSS Development Co., Ltd. Date Published : 04/24/2013 Room 609, F6, Building 13, , Yard 5 Tianhua Street Daxing District , Beijing, Beijing CHINA 79 G - - EX Powered laser surgical instruments Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II 79 N - - SY Stimulator, Light, Aesthetic Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II 79 O - - NE Powered light based non-laser surgical instrument Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II ; 79 O - - NF Powered light based non-laser surgical instrument with thermal effect Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II 79 O - - NQ electrosurgical coagulation for aesthetic Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II ; 79 O - - UH Skin resurfacing rf applicator Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II ; 79 O - - YW For the removal of fat through laser lipolysis Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II 95 R - - DW General Purpose Laser Products, Non-Medical Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II 95 R - - HL Laser therapy product Date Published: 04/24/2013 Desc: 4S Beauty System Notes: Class II

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

## 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/).