← FDA Medical Device Classifications

Adaptometer (Biophotometer)

HJW · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1050

Classification

FDA Product Code
HJW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.1050
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
0
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown