FDA Product Code
FDA Product Code PDZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253960 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | 2026-03-09 | Traditional | PDF ↗ |
| K241116 | Onycho Laser V | Terasysd&C, Inc. | 2024-07-22 | Traditional | PDF ↗ |
| K211265 | TFX-LT2000 Therapy Light | Toefx, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K221363 | AF Laser | ShenB Co., Ltd. | 2022-07-20 | Traditional | PDF ↗ |
| K190034 | REMY Medical Therapy Laser System | Footdocprenur, LLC | 2019-05-15 | Traditional | PDF ↗ |
| K153164 | LunulaLaser | Erchonia Medical, Inc. | 2016-06-03 | Traditional | PDF ↗ |
| K150138 | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | 2015-05-08 | Traditional | PDF ↗ |
| K123014 | LITECURE THERAPY SYSTEM MODEL LTS-1500 | Litecure, LLC | 2013-03-29 | Traditional | PDF ↗ |
| K121508 | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N | Fotona D.D. | 2012-12-12 | Traditional | PDF ↗ |
| K113843 | FREEDOM ND: YAG LASER SYSTEM | Lutronic Corporation | 2012-09-27 | Traditional | PDF ↗ |
| K120938 | THE PL-1064 LASER SYSTEM | Sheaumann Laser, Inc. | 2012-09-24 | Traditional | PDF ↗ |
| K113702 | FOTONA XP ND: YAG LASER SYSTEM | Fotona D.D. | 2012-03-28 | Traditional | PDF ↗ |
| K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | Alma Lasers, Inc. | 2012-03-08 | Traditional | PDF ↗ |
| K110375 | BLUESHINE'S GOLD SERIES | Blueshine Srl | 2012-02-23 | Traditional | PDF ↗ |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | Sciton, Inc | 2011-12-07 | Traditional | PDF ↗ |
| K103338 | COOLTOUCH | New Star Lasers, Inc. | 2011-11-01 | Traditional | PDF ↗ |
| K110370 | Q-CLEAR | Light Age, Inc. | 2011-09-15 | Traditional | PDF ↗ |
| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Cutera, Inc. | 2011-04-05 | Traditional | PDF ↗ |
| K093547 | PINPOINTE FOOTLASER | Pinpointe USA, Inc. | 2010-10-15 | Traditional | PDF ↗ |
Product code PDZ · Class II · General, Plastic Surgery. Data: openFDA.