PDZ · Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | PDZ |
|---|---|
| Device Name | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | Mar 9, 2026 | SESE |
| K241116 | Onycho Laser V | Terasysd&C, Inc. | Jul 22, 2024 | SESE |
| K211265 | TFX-LT2000 Therapy Light | Toefx, Inc. | Nov 17, 2022 | SESE |
| K221363 | AF Laser | ShenB Co., Ltd. | Jul 20, 2022 | SESE |
| K190034 | REMY Medical Therapy Laser System | Footdocprenur, LLC | May 15, 2019 | SESE |
| K153164 | LunulaLaser | Erchonia Medical, Inc. | Jun 3, 2016 | SESE |
| K150138 | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | May 8, 2015 | SESE |
| K123014 | LITECURE THERAPY SYSTEM MODEL LTS-1500 | Litecure, LLC | Mar 29, 2013 | SESE |
| K121508 | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N | Fotona D.D. | Dec 12, 2012 | SESE |
| K113843 | FREEDOM ND: YAG LASER SYSTEM | Lutronic Corporation | Sep 27, 2012 | SESE |
| K120938 | THE PL-1064 LASER SYSTEM | Sheaumann Laser, Inc. | Sep 24, 2012 | SESE |
| K113702 | FOTONA XP ND: YAG LASER SYSTEM | Fotona D.D. | Mar 28, 2012 | SESE |
| K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | Alma Lasers, Inc. | Mar 8, 2012 | SESE |
| K110375 | BLUESHINE'S GOLD SERIES | Blueshine Srl | Feb 23, 2012 | SESE |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | Sciton, Inc | Dec 7, 2011 | SESE |
| K103338 | COOLTOUCH | New Star Lasers, Inc. | Nov 1, 2011 | SESE |
| K110370 | Q-CLEAR | Light Age, Inc. | Sep 15, 2011 | SESE |
| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Cutera, Inc. | Apr 5, 2011 | SESE |
| K093547 | 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
