Product Code: PDZ FDA class 2 21 CFR 878.4810

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

General, Plastic Surgery

The Laser device for Temporary Increase of Clear Nail in Patients with Onychomycosis is a dermatological treatment device using laser energy to temporarily increase the amount of clear nail in patients with onychomycosis (nail fungal infection), caused by dermatophytes such as Trichophyton rubrum and T. mentagrophytes. It falls under the General and Plastic Surgery medical specialty and is classified as a Class 2 device under regulation 878.4810, requiring 510(k) premarket notification. This laser treatment offers a non-pharmacological cosmetic improvement option for affected patients. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

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Basic Information

Product Code: PDZ
Device Class: FDA class 2
Regulation Number: 878.4810
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253960	Medicell Mycosis Laser (MCML24004)	Mar 09, 2026	Substantially Equivalent	Medicell Healthcare Co.,LTD
K241116	Onycho Laser V	Jul 22, 2024	Substantially Equivalent	Terasysd&C, Inc.
K211265	TFX-LT2000 Therapy Light	Nov 17, 2022	Substantially Equivalent	Toefx, Inc.
K221363	AF Laser	Jul 20, 2022	Substantially Equivalent	ShenB Co., Ltd.
K190034	REMY Medical Therapy Laser System	May 15, 2019	Substantially Equivalent	Footdocprenur, LLC
K153164	LunulaLaser	Jun 03, 2016	Substantially Equivalent	Erchonia Medical, Inc.
K150138	Aspen Laser Systems Therapy Laser System	May 08, 2015	Substantially Equivalent	Aspen Laser Systems, LLC
K123014	LITECURE THERAPY SYSTEM MODEL LTS-1500	Mar 29, 2013	Substantially Equivalent	Litecure, LLC
K121508	LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N	Dec 12, 2012	Substantially Equivalent	Fotona D.D.
K113843	FREEDOM ND: YAG LASER SYSTEM	Sep 27, 2012	Substantially Equivalent	Lutronic Corporation
K120938	THE PL-1064 LASER SYSTEM	Sep 24, 2012	Substantially Equivalent	Sheaumann Laser, Inc.
K113702	FOTONA XP ND: YAG LASER SYSTEM	Mar 28, 2012	Substantially Equivalent	Fotona D.D.
K113810	MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES	Mar 08, 2012	Substantially Equivalent	Alma Lasers, Inc.
K110375	BLUESHINE'S GOLD SERIES	Feb 23, 2012	Substantially Equivalent	Blueshine Srl
K111483	JOULE CLEARSENSE LASER SYSTEM	Dec 07, 2011	Substantially Equivalent	Sciton, Inc
K103338	COOLTOUCH	Nov 01, 2011	Substantially Equivalent	New Star Lasers, Inc.
K110370	Q-CLEAR	Sep 15, 2011	Substantially Equivalent	Light Age, Inc.
K103626	CUTERA GENESISPLUS LASER SYSTEM	Apr 05, 2011	Substantially Equivalent	Cutera, Inc.
K093547	PINPOINTE FOOTLASER	Oct 15, 2010	Substantially Equivalent	Pinpointe USA, Inc.