← FDA Medical Device Classifications
Sunlamp Products (Pre-Standard)
RAB · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4635
Classification
- FDA Product Code
RAB- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4635
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown