Reference Source

GUANGZHOU SHANGSHI COSMETICS CO · 89-08 · CHINA

For GUANGZHOU SHANGSHI COSMETICS CO, 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 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 2026-09-30.

Firm
GUANGZHOU SHANGSHI COSMETICS CO 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
No. 2 North Street , Baiyun District , Guangzhou, Guangdong CHINA verified
Date published
09/04/2024 verified
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 each item verified
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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

GUANGZHOU SHANGSHI COSMETICS CO Date Published : 09/04/2024 No. 2 North Street , Baiyun District , Guangzhou, Guangdong 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

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

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

Source

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