Device class
Class II
Regulation 878.4810
Total clearances
4
2022-07-20 → 2026-03-09
Definition
What is Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
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.).
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4810
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Medicell Healthcare Co.,LTD |
1 |
1 |
2026-03-09 |
|
Terasysd&C, Inc. |
1 |
0 |
2024-07-22 |
|
Toefx, Inc. |
1 |
0 |
2022-11-17 |
|
ShenB Co., Ltd.
|
1 |
0 |
2022-07-20 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 96920 |
CPT
|
— |
High
|
Laser treatment of inflammatory skin lesions; fungal nail treatment via laser |
| 17000 |
CPT
|
— |
Medium
|
Destruction of skin lesion (onychomycosis); laser ablation of fungal nails |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-03-09 |
K253960 |
Medicell Healthcare Co.,LTD
|
Medicell Mycosis Laser (MCML24004) |
| 2024-07-22 |
K241116 |
Terasysd&C, Inc.
|
Onycho Laser V |
| 2022-11-17 |
K211265 |
Toefx, Inc.
|
TFX-LT2000 Therapy Light |
| 2022-07-20 |
K221363 |
ShenB Co., Ltd.
|
AF Laser |