MODEL DLASER 1000 ND;YAG LASER SYSTEM
FDA 510(k) clearance K914568 · decided 1991-11-07
Clearance details
- K-number
- K914568
- Device name
- MODEL DLASER 1000 ND;YAG LASER SYSTEM
- Applicant
- Sunrise Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-15
- Decision date
- 1991-11-07
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HYPERION LTK SYSTEM (P990078/S005) | Sunrise Technologies, Inc. | 2002-05-08 |
| SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK) (P990078/S004) | Sunrise Technologies, Inc. | 2001-03-16 |
| HYPERION LTK SYSTEM (P990078/S001) | Sunrise Technologies, Inc. | 2000-12-11 |
| HYPERION LTK SYSTEM (P990078) | Sunrise Technologies, Inc. | 2000-06-30 |