510(k) K900199

LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY by Lasag AG — Product Code HQF

K900199 is an FDA 510(k) premarket notification submitted by Lasag AG for the device "LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY". The FDA issued a decision of Substantially Equivalent on March 27, 1990. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Lasag AG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1990
Date Received
January 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type