← FDA Medical Device Classifications

Keratoprosthesis, Temporary Implant, Surgical Use

MLP · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3400

Classification

FDA Product Code

MLP

Device class

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

Regulation

21 CFR 886.3400

Review panel

OP

Medical specialty

Ophthalmic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

Y

Market data

Cleared 510(k) submissions

4

Registered establishments

1

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown