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HLR · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1350

Classification

FDA Product Code

HLR

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 886.1350

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

7

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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