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510(k) K110370

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

K110370 is an FDA 510(k) premarket notification submitted by Light Age, Inc. for the device "Q-CLEAR". The FDA issued a decision of Substantially Equivalent on September 15, 2011. The device falls under product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis), a Class II device regulated under 21 CFR 878.4810. Light Age, Inc. has at least 6 other 510(k) clearances on record.

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)

FDA data resources