Guangdong Newdermo Biotech Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 6 device types, 8 products catalogued, 4 clearances.
Guangdong Newdermo Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Brush, Dermabrasion, Manual, Pack, Hot Or Cold, Reusable and 4 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
6device types registered with the FDA
8products catalogued under its own name
4510(k) clearances
Registration
| Registered name | Guangdong Newdermo Biotech Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013178978 |
| FEI number | 3013178978 |
| DUNS | 403370499 |
| Establishment type | Manufacturer |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Building 70(C28),No.9 Huateng Road,Jinshan Village,Shiqi Town |
| Postal code | 511450 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | Class 1 | FIRMAGLOW; FIRMAGLOW Body | 2026 | 21 |
| Brush, Dermabrasion, Powered | Class 1 | Diamond Microdermabrasion Device(9004-S), Microdermabrasion Machine(ND-9004), Magic Cube Hydro-dermabrasion Machine(ND-9012), Sonic Silicone Facial Brush(ND-FC04), Microdermabrasion Machine Pro(ND-9901) | 2016 | 65 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Over-The-Counter Powered Light Based Laser For Acne-LED Light Therapy Mask(FM-01,FM-02,FM-03), LED Light Therapy Mask(FM-19K) | 2023 | 235 |
| Light Based Over The Counter Wrinkle Reduction | Class 2 | Over-The-Counter Powered Light Based Laser For Acne-LED Light Therapy Mask(FM-01,FM-02,FM-03) | 2023 | 67 |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | Over-The-Counter Powered Light Based Laser For Acne-LED Light Therapy Mask(FM-01,FM-02,FM-03) | 2023 | 59 |
| Pack, Hot Or Cold, Reusable | Class 1 | Silk’ n LumiChill | 2026 | 178 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 6 |
| Brookstone | OHS | 3 |
| Wonder Family | OHS | 2 |
| kingdo | OHS | 2 |
| Aura | OHS | 2 |
| Voguenow | OHS | 2 |
| Newdermo | OHS | 1 |
| Inia | OHS | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261052 | 2026-06-29 | OHS | Traditional | This company |
| K260946 | 2026-06-18 | OHS | Traditional | This company |
| K260202 | 2026-03-23 | OHS | Traditional | This company |
| K223544 | 2023-02-23 | OHS | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.