510(k) K241116
- Device
- Onycho Laser V
- Applicant
- Terasysd&C, Inc.
- 510(k) number
- K241116
- Product code
- PDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-22
- Date received
- 2024-04-23
- Regulation
- 878.4810
- Classification name
- Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sanghyeop Han
- Address
- Unit 1101~1108, Bldg. N, 249 Sunhwagung-Ro, Namyangju-Si Gyeonggi-Do KR 12106 12106
FDA Registration Numbers#
- 3016496662
- 3009736547
- 3015529593
- 3003542872
- 2032513
- 3007085226
- 3014577013
- 3026939957
- 3017264244
- 3004167969
- 3026668625
- 2954354
- 3005210579
- 3007674911
- 3017181358
- 3013121972
- 3030926983
- 3010972758
- 9613462
Source Documents#
Other 510(k) Records For Product Code PDZ#
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|---|---|---|---|
| K253960 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | 2026-03-09 |
| K211265 | TFX-LT2000 Therapy Light | Toefx, Inc. | 2022-11-17 |
| K221363 | AF Laser | ShenB Co., Ltd. | 2022-07-20 |
| K190034 | REMY Medical Therapy Laser System | Footdocprenur, LLC | 2019-05-15 |
| K153164 | LunulaLaser | Erchonia Medical, Inc. | 2016-06-03 |
| K150138 | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | 2015-05-08 |
| K123014 | LITECURE THERAPY SYSTEM MODEL LTS-1500 | Litecure, LLC | 2013-03-29 |
| K121508 | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N | Fotona D.D. | 2012-12-12 |
| K113843 | FREEDOM ND: YAG LASER SYSTEM | Lutronic Corporation | 2012-09-27 |
| K120938 | THE PL-1064 LASER SYSTEM | Sheaumann Laser, Inc. | 2012-09-24 |
| K113702 | FOTONA XP ND: YAG LASER SYSTEM | Fotona D.D. | 2012-03-28 |
| K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | Alma Lasers, Inc. | 2012-03-08 |
| K110375 | BLUESHINE'S GOLD SERIES | Blueshine Srl | 2012-02-23 |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | Sciton, Inc | 2011-12-07 |
| K103338 | COOLTOUCH | New Star Lasers, Inc. | 2011-11-01 |