PHOTOTOME(TM) SYSTEM 2700
FDA premarket approval P850019/S002 · decided 1987-01-09
Approval details
- PMA number
- P850019
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PHOTOTOME(TM) SYSTEM 2700
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Laser Media
- Date received
- 1986-09-08
- Decision date
- 1987-01-09
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hauppauge, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA (K872352) | Laser Media | 1987-12-30 |
| FIBERLASE II ND:YAG LASER FOR PULMONARY USE (K872351) | Laser Media | 1987-12-11 |
| FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE (K872350) | Laser Media | 1987-08-10 |
| UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM (K872031) | Laser Media | 1987-08-04 |
| SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG (K863428) | Laser Media | 1986-12-03 |
| CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER (K863583) | Laser Media | 1986-11-24 |
| FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA (K862444) | Laser Media | 1986-09-25 |
| ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM (K860063) | Laser Media | 1986-02-05 |