Laser For Gastro-Urology Use

FDA product code LNK · 60 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4810
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1983-12-21 – 1993-05-21

LNK 1993-05-21

TECHNOMED PULSOLITH 4000 LASER SYSTEM

Applicant Teknomed, Inc.

K number K925395

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LNK 1990-07-13

MDL-2000 LASERTRIPTER

Applicant Candela Laser Corp.

K number K901723

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LNK 1988-07-12

ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.

Applicant Minnesota Laser Corp.

K number K874255

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LNK 1988-07-12

ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.

Applicant Minnesota Laser Corp.

K number K874253

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LNK 1988-04-14

MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE

Applicant Sharplan Lasers, Inc.

K number K880256

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LNK 1988-04-14

MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE

Applicant Sharplan Lasers, Inc.

K number K880193

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LNK 1988-04-13

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY

Applicant Surgilase, Inc.

K number K875039

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LNK 1988-04-11

MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL

Applicant Cooper Lasersonics, Inc.

K number K880171

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LNK 1988-03-25

MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE

Applicant Lasermatic, Inc.

K number K871934

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LNK 1988-03-25

MODEL 5050 SURGILASER FOR UROLOGY USE

Applicant Lasermatic, Inc.

K number K871932

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LNK 1988-02-02

SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE

Applicant Laserguide

K number K873892

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LNK 1987-11-18

KTP/532 LASER

Applicant Laserscope

K number K873330

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LNK 1987-10-14

LASER OPTICAL FIBERS - DISPOSABLE

Applicant Optimed Therapeutics

K number K872870

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LNK 1987-09-08

SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE

Applicant Sharplan Lasers, Inc.

K number K871865

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LNK 1987-08-25

ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.

Applicant Hgm, Inc.

K number K872630

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LNK 1987-08-10

FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE

Applicant Laser Media

K number K872350

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LNK 1987-08-04

UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM

Applicant Laser Media

K number K872031

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LNK 1987-07-09

SL-100 ND:YAG LASER FOR UROLOGIC SURGERY

Applicant Medical Energy, Inc.

K number K871516

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LNK 1987-07-09

SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING

Applicant Medical Energy, Inc.

K number K871515

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LNK 1987-07-09

SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID

Applicant Medical Energy, Inc.

K number K871514

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LNK 1987-07-09

SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI

Applicant Medical Energy, Inc.

K number K871513

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LNK 1987-06-12

SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE

Applicant Sharplan Lasers, Inc.

K number K871348

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LNK 1987-05-18

MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.

Applicant Directed Energy, Inc.

K number K871032

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LNK 1987-05-18

MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.

Applicant Directed Energy, Inc.

K number K871029

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LNK 1987-05-15

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH

Applicant Directed Energy, Inc.

K number K871031

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LNK 1987-05-15

MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.

Applicant Directed Energy, Inc.

K number K871030

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LNK 1987-03-30

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE

Applicant Bio Quantum Technologies, Inc.

K number K864948

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LNK 1986-12-03

SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG

Applicant Laser Media

K number K863428

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LNK 1986-11-24

CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER

Applicant Laser Media

K number K863583

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LNK 1986-11-19

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM

Applicant Laserscope

K number K862598

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LNK 1986-08-14

CONTACT TIPS

Applicant Cooper Lasersonics, Inc.

K number K861955

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LNK 1986-08-07

ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE

Applicant Trimedyne, Inc.

K number K861331

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LNK 1986-07-25

OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO

Applicant Trimedyne, Inc.

K number K861173

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LNK 1986-06-20

#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL

Applicant Cooper Lasersonics, Inc.

K number K861903

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LNK 1986-06-17

MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL

Applicant Sharplan Industries, Inc.

K number K861047

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LNK 1986-05-02

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA

Applicant Sharplan Industries, Inc.

K number K861046

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LNK 1986-04-07

HGM, INC. LASERCATH (STERILE)

Applicant Hgm, Inc.

K number K860357

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LNK 1986-03-14

MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY

Applicant Xanar, Inc.

K number K860496

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LNK 1986-02-26

S.L.T. CONTACT LASER SYSTEM

Applicant Surgical Laser Technologies, Inc.

K number K855100

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LNK 1986-02-24

S.L.T. CONTACT LASER

Applicant Surgical Laser Technologies, Inc.

K number K855119

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LNK 1986-02-11

S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER

Applicant Surgical Laser Technologies, Inc.

K number K854669

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LNK 1986-02-05

MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY

Applicant Endo Lase, Inc.

K number K860152

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LNK 1986-02-05

ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM

Applicant Laser Media

K number K860063

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LNK 1986-01-21

FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM

Applicant Laser Media

K number K855197

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LNK 1985-12-02

LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM

Applicant Laserscope

K number K854027

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LNK 1985-11-12

HOTIP HEMOSTATIC PROBE

Applicant Trimedyne, Inc.

K number K843628

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LNK 1985-07-29

FIBERLASE 100 MEDICAL LASER SYSTEM

Applicant Laser Media

K number K852798

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LNK 1985-04-08

MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE

Applicant Cooper Lasersonics, Inc.

K number K850728

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LNK 1985-04-08

ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM

Applicant Laser Media

K number K850509

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LNK 1985-01-16

ND. YAG LASER RECTAL PATHOLOGY

Applicant Endo Lase, Inc.

K number K844460

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LNK 1985-01-16

ND:YAG LASER UROLOGICAL SURGERY

Applicant Endo Lase, Inc.

K number K844459

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LNK 1984-10-02

ND-YAG LASER FOR PALLIATION OF GI MALIGN

Applicant Endo Lase, Inc.

K number K843374

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LNK 1984-10-02

ND-YAG LASER FOR UROLOGICAL SURGERY

Applicant Endo Lase, Inc.

K number K843293

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LNK 1984-10-02

LASER FOR GENITOURINARY APPLIC. 4000

Applicant Cooper Lasersonics, Inc.

K number K843240

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LNK 1984-10-01

BIOLAS YAG 100 CILAS, ERCELAS YAG 100

Applicant Advanced Biomedical Instruments

K number K843156

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LNK 1984-08-08

COOPER LASERSONICS, 8000 ND.YAGLASER

Applicant Cooper Lasersonics, Inc.

K number K841869

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LNK 1984-05-18

YAG LASER 8000 - LOWER GI APPLICAT

Applicant Cooper Lasersonics, Inc.

K number K840142

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LNK 1984-04-02

FIBERLAS 100 MEDICAL SYSTEM

Applicant Fiberlase U.S.A.

K number K833499

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LNK 1984-02-07

MEDILAS LASER

Applicant Endo Lase, Inc.

K number K833557

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LNK 1983-12-21

MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000

Applicant Cooper Lasersonics, Inc.

K number K833480

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