Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Light Tree Ventures Europe B.V. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
182 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | 2026-05-12 | 92 | 0 |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | 2025-12-24 | 85 | 0 |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, | Light Tree Ventures Europe B.V. | 2023-07-03 | 109 | 0 |
| K223893 | Infrared Heat (Model: E0221) | Light Tree Ventures Europe B.V. | 2023-05-16 | 139 | 0 |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | 2023-04-28 | 56 | 0 |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023-04-28 | 112 | 0 |
| K230336 | CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) | Light Tree Ventures Europe B.V. | 2023-04-05 | 57 | 0 |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) | Light Tree Ventures Europe B.V. | 2023-03-15 | 57 | 0 |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023-03-09 | 93 | 0 |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B | Light Tree Ventures Europe B.V. | 2022-12-20 | 182 | 0 |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36B | Light Tree Ventures Europe B.V. | 2022-12-08 | 204 | 0 |
| K221946 | LED Light Therapy Mask (model: MK66R-B) | Light Tree Ventures Europe B.V. | 2022-11-22 | 140 | 0 |
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022-10-07 | 74 | 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