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HKI · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1120

Classification

FDA Product Code

HKI

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 886.1120

Review panel

OP

Medical specialty

Ophthalmic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

156

Registered establishments

66

Source

Authoritative

FDA Device Classification database

Machine

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