← FDA Medical Device Classifications
Over The Counter Thermal Treatment For Acne.
OZC · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5740
Classification
- FDA Product Code
OZC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.5740
- Review panel
- SU
- Medical specialty
- Physical Medicine
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For the treatment of mild to moderate inflammatory acne.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown