← FDA Medical Device Classifications
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
OKJ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4860
Classification
- FDA Product Code
OKJ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4860
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Market data
- Cleared 510(k) submissions
- 4
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown