LNK · Laser For Gastro-Urology Use
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | LNK |
|---|---|
| Device Name | Laser For Gastro-Urology Use |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | Teknomed, Inc. | May 21, 1993 | SESE |
| K901723 | MDL-2000 LASERTRIPTER | Candela Laser Corp. | Jul 13, 1990 | SESE |
| K874255 | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | Minnesota Laser Corp. | Jul 12, 1988 | SESE |
| K874253 | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | Minnesota Laser Corp. | Jul 12, 1988 | SESE |
| K880256 | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | Sharplan Lasers, Inc. | Apr 14, 1988 | SESE |
| K880193 | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE | Sharplan Lasers, Inc. | Apr 14, 1988 | SESE |
| K875039 | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | Surgilase, Inc. | Apr 13, 1988 | SESE |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Cooper Lasersonics, Inc. | Apr 11, 1988 | SESE |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Lasermatic, Inc. | Mar 25, 1988 | SESE |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | Lasermatic, Inc. | Mar 25, 1988 | SESE |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Laserguide | Feb 2, 1988 | SESE |
| K873330 | KTP/532 LASER | Laserscope | Nov 18, 1987 | SESE |
| K872870 | LASER OPTICAL FIBERS - DISPOSABLE | Optimed Therapeutics | Oct 14, 1987 | SESE |
| K871865 | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | Sharplan Lasers, Inc. | Sep 8, 1987 | SESE |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Hgm, Inc. | Aug 25, 1987 | SESE |
| K872350 | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | Laser Media | Aug 10, 1987 | SESE |
| K872031 | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | Laser Media | Aug 4, 1987 | SESE |
| K871516 | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | Medical Energy, Inc. | Jul 9, 1987 | SESE |
| K871515 | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | Medical Energy, Inc. | Jul 9, 1987 | SESE |
| K871514 | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | Medical Energy, Inc. | Jul 9, 1987 | SESE |
Top Applicants
- Laser Media — 8 clearances
- Cooper Lasersonics, Inc. — 8 clearances
- Endo Lase, Inc. — 6 clearances
- Sharplan Lasers, Inc. — 4 clearances
- Medical Energy, Inc. — 4 clearances
