Guangdong Newdermo Biotech Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Guangdong Newdermo Biotech Co., Ltd.” (first 2023, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 4 | 88 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangdong Newdermo Biotech Co., Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | 4 | 4 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
Review panels
Most recent Guangdong Newdermo Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | NFO | 2026-09-16 | 142 |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | OHS | 2026-06-29 | 90 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | OHS | 2026-06-18 | 87 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | OHS | 2026-03-23 | 59 |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | OHS | 2023-02-23 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Newdermo Biotech Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Guangdong Biolight Meditech Co., Ltd. (21 510(k)s)
- Guangdong Transtek Medical Electronics Co., Ltd. (17 510(k)s)
- Guangdong Kingfa Sci. & Tech.Co., Ltd. (14 510(k)s)
- Guangdong Optomedic Technologies, Inc. (9 510(k)s)
- Guangdong Horigen Mother & Baby Products Co., Ltd. (7 510(k)s)
- Guangdong Genial Technology Co., Ltd. (5 510(k)s)
- Guangdong Prestige Technology Co., Ltd. (5 510(k)s)
- Guangdong Jinme Medical Technology Co., Ltd. (4 510(k)s)
- Guangdong Youmeng Electrical Technology Co., Ltd. (4 510(k)s)
- Guangdong Gymda Medical Technology Co.,Ltd (2 510(k)s)
- Guangdong Kaiyang Medical Technology Co., Ltd. (2 510(k)s)
- Guangdong Xinyu Electronic and Technology Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangdong Newdermo Biotech Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Guangdong Newdermo Biotech Co., Ltd.” (first 2023, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Guangdong Newdermo Biotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangdong Newdermo Biotech Co., Ltd. is 90 days. Since 2017: 90 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangdong Newdermo Biotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are OHS (Light Based Over The Counter Wrinkle Reduction, 4); NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 1).
Next steps
- See all 5 Guangdong Newdermo Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OHS, Guangdong Newdermo Biotech Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.