510(k) K895213

MICROLASE BY LASER TRABECULOPLASTY by Keeler Instruments, Inc. — Product Code HQF

K895213 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "MICROLASE BY LASER TRABECULOPLASTY". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
August 18, 1989
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