Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Lutronic and its 3 subsidiaries with 32 510(k) clearances and 3 device recalls. The most recent is a device recall dated Aug 6, 2026: Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Lutronic and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 6, 2026 | Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of Class II · Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during t | Device recalls |
| Jan 27, 2026 | CLARITY II Laser System; Model No. 1110200210.Class II · Reports of devices sparking/popping and potentially burning patients. | Device recalls |
| Sep 4, 2025 | XERF EFFECTOR 60. Electrosurgical unit.Class II · Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for | Device recalls |
| Aug 11, 2025 | XERFK251327 · GEI | 510(k) clearances |
| Jul 31, 2025 | eCO2 3DK244060 · ONG | 510(k) clearances |
| Jan 2, 2024 | MOSAIC 3D (Surgical Laser)K233550 · ONG | 510(k) clearances |
| Dec 27, 2022 | R:GENK220974 · HQF | 510(k) clearances |
| Oct 14, 2022 | CoreLeveeK213748 · NGX | 510(k) clearances |
| Feb 4, 2022 | HOLLYWOOD SPECTRA Laser SystemK213569 · GEX | 510(k) clearances |
| Mar 26, 2021 | DermaV Laser SystemK203788 · GEX | 510(k) clearances |
| Nov 12, 2019 | LaseMD LEO Laser SystemK192331 · GEX | 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
