Device class
Class II
Regulation 878.4860
Total clearances
3
2022-10-07 → 2025-09-23
Definition
What is Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4860
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 96567 |
CPT
|
— |
Medium
|
Photodynamic therapy for lesion treatment; context-dependent on whether light-based or photothermal mechanism |
| 92004 |
CPT
|
— |
Low
|
Generic light/laser therapy code; limited specificity for cold sore treatment |
Pulse
Most recent 510(k) clearances