Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangdong Newdermo Biotech Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Ches | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 | 90 | 0 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03B | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 | 87 | 0 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 | 59 | 0 |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023-02-23 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda