PMA P990078S004
- Device
- SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
- Applicant
- Sunrise Technologies, Inc.
- PMA number
- P990078
- Supplement
- S004
- Product code
- HQF
- Decision date
- 2001-03-16
- Classification
- Laser, Ophthalmic
- Generic name
- Laser, ophthalmic
- Approval order statement
- APPROVAL FOR A SOFTWARE MODIFICATION TO THE EYE TRACKER.
Current openFDA PMA Record#
- Device
- SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
- Applicant
- Sunrise Technologies, Inc.
- PMA number
- P990078
- Supplement
- S004
- Product code
- HQF
- Generic name
- Laser, ophthalmic
- Decision date
- 2001-03-16
- Decision code
- APPR
- Date received
- 2000-12-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A SOFTWARE MODIFICATION TO THE EYE TRACKER.