← FDA Medical Device Classifications
Laser, Comb, Hair
OAP · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5500
Classification
- FDA Product Code
OAP- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.5500
- Review panel
- SU
- Medical specialty
- Physical Medicine
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Market data
- Cleared 510(k) submissions
- 107
- Registered establishments
- 64
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown