Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → PDZ — Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis # PDZ · Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis _General, Plastic Surgery · 21 CFR 878.4810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ ## Overview - **Product Code:** PDZ - **Device Name:** Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis - **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Classification Rationale (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253960](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K253960.md) | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | Mar 9, 2026 | SESE | | [K241116](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K241116.md) | Onycho Laser V | Terasysd&C, Inc. | Jul 22, 2024 | SESE | | [K211265](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K211265.md) | TFX-LT2000 Therapy Light | Toefx, Inc. | Nov 17, 2022 | SESE | | [K221363](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K221363.md) | AF Laser | ShenB Co., Ltd. | Jul 20, 2022 | SESE | | [K190034](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K190034.md) | REMY Medical Therapy Laser System | Footdocprenur, LLC | May 15, 2019 | SESE | | [K153164](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K153164.md) | LunulaLaser | Erchonia Medical, Inc. | Jun 3, 2016 | SESE | | [K150138](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K150138.md) | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | May 8, 2015 | SESE | | [K123014](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K123014.md) | LITECURE THERAPY SYSTEM MODEL LTS-1500 | Litecure, LLC | Mar 29, 2013 | SESE | | [K121508](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K121508.md) | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N | Fotona D.D. | Dec 12, 2012 | SESE | | [K113843](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K113843.md) | FREEDOM ND: YAG LASER SYSTEM | Lutronic Corporation | Sep 27, 2012 | SESE | | [K120938](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K120938.md) | THE PL-1064 LASER SYSTEM | Sheaumann Laser, Inc. | Sep 24, 2012 | SESE | | [K113702](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K113702.md) | FOTONA XP ND: YAG LASER SYSTEM | Fotona D.D. | Mar 28, 2012 | SESE | | [K113810](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K113810.md) | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | Alma Lasers, Inc. | Mar 8, 2012 | SESE | | [K110375](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K110375.md) | BLUESHINE'S GOLD SERIES | Blueshine Srl | Feb 23, 2012 | SESE | | [K111483](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K111483.md) | JOULE CLEARSENSE LASER SYSTEM | Sciton, Inc | Dec 7, 2011 | SESE | | [K103338](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K103338.md) | COOLTOUCH | New Star Lasers, Inc. | Nov 1, 2011 | SESE | | [K110370](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K110370.md) | Q-CLEAR | Light Age, Inc. | Sep 15, 2011 | SESE | | [K103626](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K103626.md) | CUTERA GENESISPLUS LASER SYSTEM | Cutera, Inc. | Apr 5, 2011 | SESE | | [K093547](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K093547.md) | PINPOINTE FOOTLASER | Pinpointe USA, Inc. | Oct 15, 2010 | SESE | ## Top Applicants - Fotona D.D. — 2 clearances - Toefx, Inc. — 1 clearance - Terasysd&C, Inc. — 1 clearance - ShenB Co., Ltd. — 1 clearance - Sheaumann Laser, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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