LNK · Class II · 21 CFR 878.4810

FDA Product Code LNK: Laser For Gastro-urology Use

Leading manufacturers include Cooper Lasersonics, Inc., Directed Energy, Inc. and Sharplan Lasers, Inc..

60
Total
60
Cleared
98d
Avg days
1983
Since

FDA 510(k) Cleared Laser For Gastro-urology Use Devices (Product Code LNK)

60 devices
1–24 of 60
Cleared Jul 13, 1990
MDL-2000 LASERTRIPTER
K901723
Candela Laser Corp.
Gastroenterology & Urology · 88d
Cleared Apr 14, 1988
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
K880193
Sharplan Lasers, Inc.
Gastroenterology & Urology · 86d
Cleared Apr 14, 1988
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256
Sharplan Lasers, Inc.
Gastroenterology & Urology · 85d
Cleared Apr 11, 1988
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
K880171
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 18, 1987
KTP/532 LASER
K873330
Laserscope
Gastroenterology & Urology · 91d
Cleared Sep 08, 1987
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865
Sharplan Lasers, Inc.
Gastroenterology & Urology · 118d
Cleared Jun 12, 1987
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348
Sharplan Lasers, Inc.
Gastroenterology & Urology · 67d
Cleared May 18, 1987
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
K871029
Directed Energy, Inc.
Gastroenterology & Urology · 63d
Cleared May 18, 1987
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032
Directed Energy, Inc.
Gastroenterology & Urology · 63d
Cleared May 15, 1987
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
K871030
Directed Energy, Inc.
Gastroenterology & Urology · 60d
Cleared May 15, 1987
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
K871031
Directed Energy, Inc.
Gastroenterology & Urology · 60d
Cleared Nov 19, 1986
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
K862598
Laserscope
Gastroenterology & Urology · 141d
Cleared Aug 14, 1986
CONTACT TIPS
K861955
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 07, 1986
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
K861331
Trimedyne, Inc.
Gastroenterology & Urology · 120d
Cleared Jul 25, 1986
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
K861173
Trimedyne, Inc.
Gastroenterology & Urology · 119d
Cleared Jun 20, 1986
#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL
K861903
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 35d
Cleared Feb 26, 1986
S.L.T. CONTACT LASER SYSTEM
K855100
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Feb 24, 1986
S.L.T. CONTACT LASER
K855119
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 11, 1986
S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
K854669
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 82d
Cleared Dec 02, 1985
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
K854027
Laserscope
Gastroenterology & Urology · 62d
Cleared Nov 12, 1985
HOTIP HEMOSTATIC PROBE
K843628
Trimedyne, Inc.
Gastroenterology & Urology · 424d
Cleared Apr 08, 1985
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
K850728
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 45d
Cleared Oct 02, 1984
LASER FOR GENITOURINARY APPLIC. 4000
K843240
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 41d
Cleared Aug 08, 1984
COOPER LASERSONICS, 8000 ND.YAGLASER
K841869
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 96d

About Product Code LNK - Regulatory Context