← FDA Medical Device Classifications

Prism, Bar, Ophthalmic

HKW · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1650

Classification

FDA Product Code

HKW

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 886.1650

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

2

Registered establishments

16

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown