← FDA Medical Device Classifications

Intraocular Lens

HQL · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.3600

Classification

FDA Product Code

HQL

Device class

Class III — High Risk (PMA approval required, life-sustaining)

Regulation

21 CFR 886.3600

Review panel

OP

Medical specialty

Ophthalmic

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

5

Registered establishments

57

Source

Authoritative

FDA Device Classification database

Machine

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