Cleared Traditional

LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY

K900199 · Lasag AG · Ophthalmic

Mar 1990

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K900199 is an FDA 510(k) clearance for the LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Lasag AG (Claremont, US). The FDA issued a Cleared decision on March 27, 1990, 70 days after receiving the submission on January 16, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K900199 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1990
Decision Date	March 27, 1990
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—