510(k) K921607

IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE by Chiron Vision Corp. — Product Code HQC

K921607 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE". The FDA issued a decision of Substantially Equivalent on June 30, 1992. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1992
Date Received
April 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type