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HKY · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1930

Classification

FDA Product Code

HKY

Device class

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

Regulation

21 CFR 886.1930

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

56

Registered establishments

65

Source

Authoritative

FDA Device Classification database

Machine

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