← FDA Medical Device Classifications

Laser For Gastro-Urology Use

LNK · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4810

Classification

FDA Product Code

LNK

Device class

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

Regulation

21 CFR 878.4810

Review panel

GU

Medical specialty

General, Plastic Surgery

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

60

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown