The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Laser Contact Lenses Cga 1, Cgi 1, Cgp 1, Cgv 1.
Device ID | K871245 |
510k Number | K871245 |
Device Name: | LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 |
Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
Contact | Deborah Helenihi |
Correspondent | Deborah Helenihi CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
Product Code | LQJ |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-27 |
Decision Date | 1987-05-07 |