← FDA Medical Device Classifications

Light, Ultraviolet, Dermatological

FTC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4630

Classification

FDA Product Code
FTC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4630
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y

Market data

Cleared 510(k) submissions
272
Registered establishments
24

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown