# K110370: Q-Clear

- Pathway: 510(k) (Traditional)
- Applicant: Light Age, Inc.
- Decided: Sep 15, 2011 after 219 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 120 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033259: Light Age Q-Clear Laser, Model 701-1101, Light Age, Inc. (2004) Summary page 1.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 1.
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K061436: Palomar Q-Yag 5 ND:Yag Laser System, Palomar Medical Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K113810: Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules (2012), 34 descendants of its own
- K133837: Viora V-Total (2014), 33 descendants of its own
- K142093: V20 System (2014), 32 descendants of its own
- K150035: V10 system (2015), 31 descendants of its own
- K153568: InMode Plus System (2016), 18 descendants of its own

## Indications for use
The Light Age, Inc. Q-Clear™ Nd:YAG Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the incision, excision, vaporization of soft tissues. The Light Age, Inc. Q-Clear™ Nd:YAG Laser is indicated for the following uses: The 1064nm wavelength is indicated for: 1. Podiatry — for incision, excision, vaporization, coagulation of soft tissues including: Matrixectomy Warts including periungual, subungual, and plantar warts Radical nail excision Neuromas The Q-Clear™ Laser System is indicated for use 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.) 2. Dermatology and Plastic Surgery - for incision, excision, vaporization, coagulation of soft tissues including: Lesions of the skin and subcutaneous tissue Spider veins Plantar Warts Periungual and subungual warts Debridement of decubitus ulcer Treatment of keloids 3. General Dermatology Dark ink tattoo removal Treatment of pigmented lesions (particularly Nevus of Ota) Removal or lightening of hair Skin resurfacing with or without adjuvant preparation Treatment of common Nevi The 532 nm wavelength is indicated for: 1. Dermatology and Plastic Surgery - for incision, excision, vaporization, coagulation of soft tissues including spider veins: 2. General Dermatology Removal of light ink (red, tan, purple, and orange) tattoos Treatment of common nevi Treatment of café-au-lait spots Treatment of seborrheic keratoses Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)

Source page: https://510kreport.com/device/K110370
Methodology: https://510kreport.com/methodology