510(k) K844460
- Device
- ND. YAG LASER RECTAL PATHOLOGY
- Applicant
- ENDO LASE, INC.
- 510(k) number
- K844460
- Product code
- LNK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-16
- Date received
- 1984-11-15
- Regulation
- 878.4810
- Classification name
- Laser For Gastro-urology Use
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN S KAHAN
- Address
- Attn: Jonathan S. Kahan 815 Connecticut Ave. Washington DC US 20006 20006
FDA Registration Numbers#
- 3004167969
- 3009736547
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LNK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | Teknomed, Inc. | 1993-05-21 |
| K901723 | MDL-2000 LASERTRIPTER | Candela Laser Corp. | 1990-07-13 |
| K874255 | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | Minnesota Laser Corp. | 1988-07-12 |
| K874253 | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | Minnesota Laser Corp. | 1988-07-12 |
| K880256 | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | Sharplan Lasers, Inc. | 1988-04-14 |
| K880193 | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE | Sharplan Lasers, Inc. | 1988-04-14 |
| K875039 | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | Surgilase, Inc. | 1988-04-13 |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Cooper Lasersonics, Inc. | 1988-04-11 |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Lasermatic, Inc. | 1988-03-25 |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | Lasermatic, Inc. | 1988-03-25 |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Laserguide | 1988-02-02 |
| K873330 | KTP/532 LASER | Laserscope | 1987-11-18 |
| K872870 | LASER OPTICAL FIBERS - DISPOSABLE | Optimed Therapeutics | 1987-10-14 |
| K871865 | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | Sharplan Lasers, Inc. | 1987-09-08 |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Hgm, Inc. | 1987-08-25 |
Legacy Summary#
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FDA Review#
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