SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
FDA 510(k) clearance K863428 · decided 1986-12-03
Clearance details
- K-number
- K863428
- Device name
- SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
- Applicant
- Laser Media
- Decision
- Substantially Equivalent
- Date received
- 1986-09-04
- Decision date
- 1986-12-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LNK
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hauppauge, NY, 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 |
|---|---|---|
| TECHNOMED PULSOLITH 4000 LASER SYSTEM (K925395) | Teknomed, Inc. | 1993-05-21 |
| MDL-2000 LASERTRIPTER (K901723) | Candela Laser Corp. | 1990-07-13 |
| ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (K874255) | Minnesota Laser Corp. | 1988-07-12 |
| ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (K874253) | Minnesota Laser Corp. | 1988-07-12 |
| MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (K880256) | Sharplan Lasers, Inc. | 1988-04-14 |
| MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (K880193) | Sharplan Lasers, Inc. | 1988-04-14 |
| ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (K875039) | Surgilase, Inc. | 1988-04-13 |
| MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (K880171) | Cooper Lasersonics, Inc. | 1988-04-11 |
| MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (K871934) | Lasermatic, Inc. | 1988-03-25 |
| MODEL 5050 SURGILASER FOR UROLOGY USE (K871932) | Lasermatic, Inc. | 1988-03-25 |
| SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (K873892) | Laserguide | 1988-02-02 |
| KTP/532 LASER (K873330) | Laserscope | 1987-11-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PHOTOTOME(TM) SYSTEM 2700 (P850019/S002) | Laser Media | 1987-01-09 |
| PHOTOTOME(TM) SYSTEM 2700 (P850019/S001) | Laser Media | 1985-12-24 |
| PHOTOTOME(TM) SYSTEM 2700 (P850019) | Laser Media | 1985-08-08 |