OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
FDA 510(k) clearance K902263 · decided 1990-07-23
Clearance details
- K-number
- K902263
- Device name
- OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
- Applicant
- Trimedyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-21
- Decision date
- 1990-07-23
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- GGX
- Device class
- 1
- Regulation number
- 864.6160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tustin, 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.
| Record | Firm | Date |
|---|---|---|
| CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (K894389) | Catachem, Inc. | 1989-10-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S026) | Trimedyne, Inc. | 1994-03-17 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S016) | Trimedyne, Inc. | 1994-03-17 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S027) | Trimedyne, Inc. | 1994-03-01 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S015) | Trimedyne, Inc. | 1992-03-20 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S014) | Trimedyne, Inc. | 1992-01-29 |
| MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013) | Trimedyne, Inc. | 1991-08-20 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025) | Trimedyne, Inc. | 1991-02-25 |
| 2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER (P870043/S011) | Trimedyne, Inc. | 1990-11-14 |