← FDA Medical Device Classifications

Reader, Prism, Ophthalmic

HJX · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.5810

Classification

FDA Product Code

HJX

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 886.5810

Review panel

OP

Medical specialty

Ophthalmic

Submission type

4

GMP exempt

Y

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

9

Source

Authoritative

FDA Device Classification database

Machine

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