← FDA Medical Device Classifications

Fluid, Intraocular

LWL · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.4275

Classification

FDA Product Code

LWL

Device class

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

Regulation

21 CFR 886.4275

Review panel

OP

Medical specialty

Ophthalmic

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

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