← FDA Medical Device Classifications

Spectacle, Operating (Loupe), Ophthalmic

HOH · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4770

Classification

FDA Product Code

HOH

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 886.4770

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

3

Registered establishments

16

Source

Authoritative

FDA Device Classification database

Machine

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