510(k) K110370

Q-CLEAR by Light Age, Inc. — Product Code PDZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 15, 2011
Date Received: February 8, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

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.).

Other clearances by Light Age, Inc.

K113115 — EPICARE YAG (April 3, 2012)
K091625 — EPICARE-DUO LASER SYSTEM (November 3, 2009)
K032991 — LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX (September 14, 2004)
K033259 — LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 (February 25, 2004)
K983977 — LIGHT AGE EPICARE ALEXANDRITE LASER (January 7, 1999)
K980131 — ALEX TA2 ERASER (February 17, 1998)

Other clearances for product code PDZ

K253960 — Medicell Mycosis Laser (MCML24004) (March 9, 2026)
K241116 — Onycho Laser V (July 22, 2024)
K211265 — TFX-LT2000 Therapy Light (November 17, 2022)
K221363 — AF Laser (July 20, 2022)
K190034 — REMY Medical Therapy Laser System (May 15, 2019)
K153164 — LunulaLaser (June 3, 2016)
K150138 — Aspen Laser Systems Therapy Laser System (May 8, 2015)
K123014 — LITECURE THERAPY SYSTEM MODEL LTS-1500 (March 29, 2013)
K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (December 12, 2012)
K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)