510(k) K871245

LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 by Chiron Vision Corp. — Product Code LQJ

K871245 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1". The FDA issued a decision of Substantially Equivalent on May 7, 1987. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), 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
May 7, 1987
Date Received
March 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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