← FDA Medical Device Classifications

Shell, Scleral

HQT · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3800

Classification

FDA Product Code

HQT

Device class

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

Regulation

21 CFR 886.3800

Review panel

OP

Medical specialty

Ophthalmic

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

4

Registered establishments

11

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown