Reference Source

Beijing ADSS Development Co., Ltd. · 89-08 · CHINA

For Beijing ADSS Development Co., Ltd., import alert is 89-08; country is CHINA; 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 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 listed twice: 02/01/2024 and 04/24/2013; address is listed twice: Southern Area , Fuda Road - Tongsheng Road , Langfang, Hebei CHINA and Room 609, F6, Building 13, , Yard 5 Tianhua Street Daxing District , Beijing, Beijing CHINA, verified against its source on 2026-09-30.

Firm
Beijing ADSS Development Co., Ltd. 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
CHINA verified
Address
Southern Area , Fuda Road - Tongsheng Road , Langfang, Hebei CHINA verified
Room 609, F6, Building 13, , Yard 5 Tianhua Street Daxing District , Beijing, Beijing CHINA also listed
Date published
02/01/2024 verified
04/24/2013 also listed
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 each item verified
Product
PDT Machine | Beauty Machine | PDT Machine | Beauty Machine each item verified
FDA notes
Class II | Class II | Class II ; | Class II | Class II ; | Class II ; | Class II | Class II | Class II also on this page
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Beijing ADSS Development Co., Ltd. Date Published : 02/01/2024 Southern Area , Fuda Road - Tongsheng Road , Langfang, Hebei CHINA

— 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 and Product

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

— all from accessdata.fda.gov, retrieved 2026-09-15

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

— accessdata.fda.gov, retrieved 2026-09-15

Product code

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

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