← FDA Medical Device Classifications

Eye, Artificial, Non-Custom

HQH · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.3200

Classification

FDA Product Code
HQH
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.3200
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
6
Registered establishments
28

Source

Authoritative
FDA Device Classification database
Machine
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