PMA P990078S001
- Device
- HYPERION LTK SYSTEM
- Applicant
- Sunrise Technologies, Inc.
- PMA number
- P990078
- Supplement
- S001
- Product code
- HQF
- Decision date
- 2000-12-11
- Classification
- Laser, Ophthalmic
- Generic name
- Laser, ophthalmic
- Approval order statement
- APPROVAL FOR A CHANGE IN THE WARNING SECTION OF THE LABELING.
Current openFDA PMA Record#
- Device
- HYPERION LTK SYSTEM
- Applicant
- Sunrise Technologies, Inc.
- PMA number
- P990078
- Supplement
- S001
- Product code
- HQF
- Generic name
- Laser, ophthalmic
- Decision date
- 2000-12-11
- Decision code
- APPR
- Date received
- 2000-11-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE WARNING SECTION OF THE LABELING.