510(k) K885164

LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM by Chiron Vision Corp. — Product Code HQF

K885164 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 10, 1989. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1989
Date Received
December 13, 1988
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