OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
FDA 510(k) clearance K870505 · decided 1987-08-07
Clearance details
- K-number
- K870505
- Device name
- OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
- Applicant
- Trimedyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-04
- Decision date
- 1987-08-07
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- LLO
- Device class
- 2
- Regulation number
- 874.4500
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Santa Ana, 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 |
|---|---|---|
| SLT CLMD CONTACT LASER (K884815) | Surgical Laser Technologies, Inc. | 1988-12-22 |
| SURGILASE YAG 100 FOR GYNECOLOGY USE (K881499) | Surgilase, Inc. | 1988-04-29 |
| LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (K880592) | Laser Peripherals, LLC | 1988-04-25 |
| MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K880170) | Cooper Lasersonics, Inc. | 1988-03-24 |
| ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (K874254) | Minnesota Laser Corp. | 1988-03-04 |
| SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (K875104) | Laserguide | 1988-02-02 |
| MODEL 5050 SURGILASER FOR PULMONARY USE (K871876) | Lasermatic, Inc. | 1988-01-22 |
| FIBERLASE II ND:YAG LASER FOR PULMONARY USE (K872351) | Laser Media | 1987-12-11 |
| SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K871511) | Medical Energy, Inc. | 1987-07-21 |
| 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (K862698) | Cooper Lasersonics, Inc. | 1986-08-05 |
| LASER BRONCHOSCOPE SYSTEM (K861921) | Pilling Co. | 1986-06-02 |
| CO2 LASER BRONCHOSCOPE SYSTEM (K861583) | Richard Wolf Medical Instruments Corp. | 1986-05-21 |
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 |