← FDA Medical Device Classifications

Lenses, Soft Contact, Extended Wear

LPM · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.5925

Classification

FDA Product Code

LPM

Device class

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

Regulation

21 CFR 886.5925

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

0

Registered establishments

51

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown