Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesthetic Technology, 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) |
|---|---|---|---|---|---|
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (10 | Aesthetic Technology, Ltd. | 2024-06-04 | 130 | 0 |
| K212275 | Dermalux Flex MD | Aesthetic Technology, Ltd. | 2021-11-18 | 121 | 0 |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | 2020-12-16 | 147 | 0 |
| K200659 | Dermalux Tri-Wave MD | Aesthetic Technology, Ltd. | 2020-05-09 | 58 | 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