Data / Medical devices / China / Guangdong Newdermo Biotech Co., Ltd
Guangdong Newdermo Biotech Co., Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 5 510(k) clearances
Guangdong Newdermo Biotech Co., Ltd is registered with the FDA (registration 3013178978) in Guangzhou Guangdong, China. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013178978
- Address
- Building 70(C28),No.9 Huateng Road,Jinshan Village,Shiqi Town Panyu District, Guangzhou Guangdong, China, 511450
- Owner or operator
- Guangdong Newdermo Biotech Co., Ltd (10053680)
- Roles
- Manufacturer
- First device listed
- December 30, 2016
- Registered through
- 2027
- Brand names listed
- Cooling Gel Mask, Diamond Microdermabrasion Device(9004-S), FIRMAGLOW; FIRMAGLOW Body, LED Face Mask 100 Cool+, LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K), LED Light Therapy Mask(FM-19K), LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA), LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Manufacturer | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | NFO | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
| June 29, 2026 | K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | OHS | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
| June 18, 2026 | K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | OHS | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
| March 23, 2026 | K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | OHS | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
| February 23, 2023 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | OHS | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Brush, Dermabrasion, Manual
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.