Cleared Traditional

K801336 - MODEL 900K PHOTOCOAGULATOR
(FDA 510(k) Clearance)

K801336 · Coherent Medical Division · Ophthalmic

Jul 1980

Decision

54d

Days

Class 2

Risk

K801336 is an FDA 510(k) clearance for the MODEL 900K PHOTOCOAGULATOR. This device is classified as a Laser, Ophthalmic (Class II — Special Controls, product code HQF).

Submitted by Coherent Medical Division (Walker, US). The FDA issued a Cleared decision on July 28, 1980, 54 days after receiving the submission on June 4, 1980.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K801336 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1980
Decision Date	July 28, 1980
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—