← FDA Medical Device Classifications

Light, Surgical, Instrument

FSQ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4580

Classification

FDA Product Code
FSQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4580
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
7
Registered establishments
26

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown