HYPERION LTK SYSTEM
FDA premarket approval P990078/S005 · decided 2002-05-08
Approval details
- PMA number
- P990078
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYPERION LTK SYSTEM
- Generic name
- Laser, ophthalmic
- Applicant
- Sunrise Technologies, Inc.
- Date received
- 2001-08-20
- Decision date
- 2002-05-08
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- HQF
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT A-PLUS/C-MAC, FREMONT, CALIFORNIA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SUNRISE CURING LAMP (K962192) | Sunrise Technologies, Inc. | 1996-09-03 |
| SLASE 210 PLUS HOLMIUM LASER SYSTEM (K942542) | Sunrise Technologies, Inc. | 1994-09-01 |
| MICROPREP CAVITY PREPERATION SYSTEM (K932997) | Sunrise Technologies, Inc. | 1994-04-25 |
| SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS (K933007) | Sunrise Technologies, Inc. | 1994-01-10 |
| MODEL 5030 SUCTION HANDPIECE SYSTEM (K933017) | Sunrise Technologies, Inc. | 1993-07-26 |
| UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER (K931774) | Sunrise Technologies, Inc. | 1993-07-22 |
| 8-WATT PULSED DENTAL LASER SYSTEM (K930789) | Sunrise Technologies, Inc. | 1993-05-21 |
| 2.5 WATT PULSED DENTAL LASER SYSTEM (K930879) | Sunrise Technologies, Inc. | 1993-05-21 |