Atlas FDA

PDZ

19 FDA 510(k) clearances · Product code

186 daysmedian time to decision
379 days90th percentile
19clearances measured

FDA profile

Official device name
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
FDA definition
For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
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RecordFirmDate
Medicell Mycosis Laser (MCML24004) (K253960)Medicell Healthcare Co.,LTD2026-03-09
Onycho Laser V (K241116)Terasysd&C, Inc.2024-07-22
TFX-LT2000 Therapy Light (K211265)Toefx, Inc.2022-11-17
AF Laser (K221363)ShenB Co., Ltd.2022-07-20
REMY Medical Therapy Laser System (K190034)Footdocprenur, LLC2019-05-15
LunulaLaser (K153164)Erchonia Medical, Inc.2016-06-03
Aspen Laser Systems Therapy Laser System (K150138)Aspen Laser Systems, LLC2015-05-08
LITECURE THERAPY SYSTEM MODEL LTS-1500 (K123014)Litecure, LLC2013-03-29
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (K121508)Fotona D.D.2012-12-12
FREEDOM ND: YAG LASER SYSTEM (K113843)Lutronic Corporation2012-09-27
THE PL-1064 LASER SYSTEM (K120938)Sheaumann Laser, Inc.2012-09-24
FOTONA XP ND: YAG LASER SYSTEM (K113702)Fotona D.D.2012-03-28
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES (K113810)Alma Lasers, Inc.2012-03-08
BLUESHINE'S GOLD SERIES (K110375)Blueshine Srl2012-02-23
JOULE CLEARSENSE LASER SYSTEM (K111483)Sciton, Inc2011-12-07
COOLTOUCH (K103338)New Star Lasers, Inc.2011-11-01
Q-CLEAR (K110370)Light Age, Inc.2011-09-15
CUTERA GENESISPLUS LASER SYSTEM (K103626)Cutera, Inc.2011-04-05
PINPOINTE FOOTLASER (K093547)Pinpointe USA, Inc.2010-10-15

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Every clearance here is in the API, with alerts when new ones post.