Product Code: LNK FDA class 2 21 CFR 878.4810

Laser For Gastro-Urology Use

General, Plastic Surgery

Laser for Gastro-Urology Use is a laser surgical system applied in gastroenterological and urological procedures, such as fragmentation of urinary calculi (kidney stones), treatment of benign prostatic hyperplasia, ablation of bladder tumors, or treatment of gastrointestinal lesions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNK, regulated under 21 CFR 878.4810, within the General/Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LNK
Device Class: FDA class 2
Regulation Number: 878.4810
Medical Specialty: General, Plastic Surgery
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 60 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K925395	TECHNOMED PULSOLITH 4000 LASER SYSTEM	May 21, 1993	Substantially Equivalent	Teknomed, Inc.
K901723	MDL-2000 LASERTRIPTER	Jul 13, 1990	Substantially Equivalent	Candela Laser Corp.
K874255	ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.	Jul 12, 1988	Substantially Equivalent	Minnesota Laser Corp.
K874253	ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.	Jul 12, 1988	Substantially Equivalent	Minnesota Laser Corp.
K880256	MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE	Apr 14, 1988	Substantially Equivalent	Sharplan Lasers, Inc.
K880193	MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE	Apr 14, 1988	Substantially Equivalent	Sharplan Lasers, Inc.
K875039	ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY	Apr 13, 1988	Substantially Equivalent	Surgilase, Inc.
K880171	MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL	Apr 11, 1988	Substantially Equivalent	Cooper Lasersonics, Inc.
K871934	MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE	Mar 25, 1988	Substantially Equivalent	Lasermatic, Inc.
K871932	MODEL 5050 SURGILASER FOR UROLOGY USE	Mar 25, 1988	Substantially Equivalent	Lasermatic, Inc.
K873892	SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE	Feb 02, 1988	Substantially Equivalent	Laserguide
K873330	KTP/532 LASER	Nov 18, 1987	Substantially Equivalent	Laserscope
K872870	LASER OPTICAL FIBERS - DISPOSABLE	Oct 14, 1987	Substantially Equivalent	Optimed Therapeutics
K871865	SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE	Sep 08, 1987	Substantially Equivalent	Sharplan Lasers, Inc.
K872630	ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.	Aug 25, 1987	Substantially Equivalent	Hgm, Inc.
K872350	FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE	Aug 10, 1987	Substantially Equivalent	Laser Media
K872031	UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM	Aug 04, 1987	Substantially Equivalent	Laser Media
K871516	SL-100 ND:YAG LASER FOR UROLOGIC SURGERY	Jul 09, 1987	Substantially Equivalent	Medical Energy, Inc.
K871515	SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING	Jul 09, 1987	Substantially Equivalent	Medical Energy, Inc.
K871514	SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID	Jul 09, 1987	Substantially Equivalent	Medical Energy, Inc.
K871513	SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI	Jul 09, 1987	Substantially Equivalent	Medical Energy, Inc.
K871348	SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE	Jun 12, 1987	Substantially Equivalent	Sharplan Lasers, Inc.
K871032	MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.	May 18, 1987	Substantially Equivalent	Directed Energy, Inc.
K871029	MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.	May 18, 1987	Substantially Equivalent	Directed Energy, Inc.
K871031	10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH	May 15, 1987	Substantially Equivalent	Directed Energy, Inc.
K871030	MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.	May 15, 1987	Substantially Equivalent	Directed Energy, Inc.
K864948	ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE	Mar 30, 1987	Substantially Equivalent	Bio Quantum Technologies, Inc.
K863428	SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG	Dec 03, 1986	Substantially Equivalent	Laser Media
K863583	CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER	Nov 24, 1986	Substantially Equivalent	Laser Media
K862598	LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM	Nov 19, 1986	Substantially Equivalent	Laserscope
K861955	CONTACT TIPS	Aug 14, 1986	Substantially Equivalent	Cooper Lasersonics, Inc.
K861331	ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE	Aug 07, 1986	Substantially Equivalent	Trimedyne, Inc.
K861173	OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO	Jul 25, 1986	Substantially Equivalent	Trimedyne, Inc.
K861903	#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL	Jun 20, 1986	Substantially Equivalent	Cooper Lasersonics, Inc.
K861047	MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL	Jun 17, 1986	Substantially Equivalent	Sharplan Industries, Inc.
K861046	MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA	May 02, 1986	Substantially Equivalent	Sharplan Industries, Inc.
K860357	HGM, INC. LASERCATH (STERILE)	Apr 07, 1986	Substantially Equivalent	Hgm, Inc.
K860496	MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY	Mar 14, 1986	Substantially Equivalent	Xanar, Inc.
K855100	S.L.T. CONTACT LASER SYSTEM	Feb 26, 1986	Substantially Equivalent	Surgical Laser Technologies, Inc.
K855119	S.L.T. CONTACT LASER	Feb 24, 1986	Substantially Equivalent	Surgical Laser Technologies, Inc.
K854669	S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER	Feb 11, 1986	Substantially Equivalent	Surgical Laser Technologies, Inc.
K860152	MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY	Feb 05, 1986	Substantially Equivalent	Endo Lase, Inc.
K860063	ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM	Feb 05, 1986	Substantially Equivalent	Laser Media
K855197	FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM	Jan 21, 1986	Substantially Equivalent	Laser Media
K854027	LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM	Dec 02, 1985	Substantially Equivalent	Laserscope
K843628	HOTIP HEMOSTATIC PROBE	Nov 12, 1985	Substantially Equivalent	Trimedyne, Inc.
K852798	FIBERLASE 100 MEDICAL LASER SYSTEM	Jul 29, 1985	Substantially Equivalent	Laser Media
K850728	MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE	Apr 08, 1985	Substantially Equivalent	Cooper Lasersonics, Inc.
K850509	ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM	Apr 08, 1985	Substantially Equivalent	Laser Media
K844460	ND. YAG LASER RECTAL PATHOLOGY	Jan 16, 1985	Substantially Equivalent	Endo Lase, Inc.
K844459	ND:YAG LASER UROLOGICAL SURGERY	Jan 16, 1985	Substantially Equivalent	Endo Lase, Inc.
K843374	ND-YAG LASER FOR PALLIATION OF GI MALIGN	Oct 02, 1984	Substantially Equivalent	Endo Lase, Inc.
K843293	ND-YAG LASER FOR UROLOGICAL SURGERY	Oct 02, 1984	Substantially Equivalent	Endo Lase, Inc.
K843240	LASER FOR GENITOURINARY APPLIC. 4000	Oct 02, 1984	Substantially Equivalent	Cooper Lasersonics, Inc.
K843156	BIOLAS YAG 100 CILAS, ERCELAS YAG 100	Oct 01, 1984	Substantially Equivalent	Advanced Biomedical Instruments
K841869	COOPER LASERSONICS, 8000 ND.YAGLASER	Aug 08, 1984	Substantially Equivalent	Cooper Lasersonics, Inc.
K840142	YAG LASER 8000 - LOWER GI APPLICAT	May 18, 1984	Substantially Equivalent	Cooper Lasersonics, Inc.
K833499	FIBERLAS 100 MEDICAL SYSTEM	Apr 02, 1984	Substantially Equivalent	Fiberlase U.S.A.
K833557	MEDILAS LASER	Feb 07, 1984	Substantially Equivalent	Endo Lase, Inc.
K833480	MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000	Dec 21, 1983	Substantially Equivalent	Cooper Lasersonics, Inc.