510(k) K871245
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