MEDITEC OPL3 ND:YAG LASER
FDA premarket approval P830025 · decided 1985-01-14
Approval details
- PMA number
- P830025
- Trade name
- MEDITEC OPL3 ND:YAG LASER
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Medical Laser, Inc.
- Date received
- 1983-06-02
- Decision date
- 1985-01-14
- Days to decision
- 592 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chevy Chase, MD
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LASER ENDOSCOPE DISC DECOMPRESSION KITS (K913136) | Medical Laser, Inc. | 1991-11-01 |
| MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (K912265) | Medical Laser, Inc. | 1991-10-10 |
| SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (K912447) | Medical Laser, Inc. | 1991-09-27 |
| MODIFIED SERIES 2100 ENDOSCOPES (K912089) | Medical Laser, Inc. | 1991-08-12 |
| MEDILASE SERIES 2200 ENDOSCOPE (K901464) | Medical Laser, Inc. | 1990-08-07 |
| MEDILASE SERIES 2100 ENDOSCOPE (K900894) | Medical Laser, Inc. | 1990-06-22 |
| MEDILASE 5010 ENDOSCOPE CONSOLE (K900380) | Medical Laser, Inc. | 1990-05-15 |
| MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (K895837) | Medical Laser, Inc. | 1989-12-14 |