Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Guangdong Newdermo Biotech Co., Ltd. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Sep 16, 2026: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 16, 2026 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))K261370 · NFO | 510(k) clearances |
| Jun 29, 2026 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)K261052 · OHS | 510(k) clearances |
| Jun 18, 2026 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)K260946 · OHS | 510(k) clearances |
| Mar 23, 2026 | LED Light Therapy Masks (LumiLips FAC07NA)K260202 · OHS | 510(k) clearances |
| Feb 23, 2023 | LED light therapy mask (FM-01, FM-02, FM-03)K223544 · OHS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
