Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LNK — Predicate Candidate Screening

60 FDA 510(k) clearances under this product code; the 50 most recent screened below.

80 daysmedian FDA review time

207 days90th percentile

60clearances measured

K-number	Device	Applicant	Decided	Review days
K925395	TECHNOMED PULSOLITH 4000 LASER SYSTEM	Teknomed, Inc.	1993-05-21	207
K901723	MDL-2000 LASERTRIPTER	Candela Laser Corp.	1990-07-13	88
K874255	ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.	Minnesota Laser Corp.	1988-07-12	266
K874253	ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.	Minnesota Laser Corp.	1988-07-12	266
K880256	MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE	Sharplan Lasers, Inc.	1988-04-14	85
K880193	MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE	Sharplan Lasers, Inc.	1988-04-14	86
K875039	ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY	Surgilase, Inc.	1988-04-13	128
K880171	MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL	Cooper Lasersonics, Inc.	1988-04-11	87
K871934	MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE	Lasermatic, Inc.	1988-03-25	311
K871932	MODEL 5050 SURGILASER FOR UROLOGY USE	Lasermatic, Inc.	1988-03-25	311
K873892	SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE	Laserguide	1988-02-02	132
K873330	KTP/532 LASER	Laserscope	1987-11-18	91
K872870	LASER OPTICAL FIBERS - DISPOSABLE	Optimed Therapeutics	1987-10-14	86
K871865	SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE	Sharplan Lasers, Inc.	1987-09-08	118
K872630	ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.	Hgm, Inc.	1987-08-25	50
K872350	FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE	Laser Media	1987-08-10	54
K872031	UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM	Laser Media	1987-08-04	70
K871513	SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI	Medical Energy, Inc.	1987-07-09	80
K871516	SL-100 ND:YAG LASER FOR UROLOGIC SURGERY	Medical Energy, Inc.	1987-07-09	80
K871515	SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING	Medical Energy, Inc.	1987-07-09	80
K871514	SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID	Medical Energy, Inc.	1987-07-09	80
K871348	SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE	Sharplan Lasers, Inc.	1987-06-12	67
K871029	MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.	Directed Energy, Inc.	1987-05-18	63
K871032	MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.	Directed Energy, Inc.	1987-05-18	63
K871030	MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.	Directed Energy, Inc.	1987-05-15	60
K871031	10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH	Directed Energy, Inc.	1987-05-15	60
K864948	ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE	Bio Quantum Technologies, Inc.	1987-03-30	103
K863428	SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG	Laser Media	1986-12-03	90
K863583	CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER	Laser Media	1986-11-24	76
K862598	LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM	Laserscope	1986-11-19	141
K861955	CONTACT TIPS	Cooper Lasersonics, Inc.	1986-08-14	86
K861331	ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE	Trimedyne, Inc.	1986-08-07	120
K861173	OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO	Trimedyne, Inc.	1986-07-25	119
K861903	#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL	Cooper Lasersonics, Inc.	1986-06-20	35
K861047	MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL	Sharplan Industries, Inc.	1986-06-17	91
K861046	MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA	Sharplan Industries, Inc.	1986-05-02	45
K860357	HGM, INC. LASERCATH (STERILE)	Hgm, Inc.	1986-04-07	67
K860496	MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY	Xanar, Inc.	1986-03-14	32
K855100	S.L.T. CONTACT LASER SYSTEM	Surgical Laser Technologies, Inc.	1986-02-26	65
K855119	S.L.T. CONTACT LASER	Surgical Laser Technologies, Inc.	1986-02-24	63
K854669	S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER	Surgical Laser Technologies, Inc.	1986-02-11	82
K860063	ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM	Laser Media	1986-02-05	30
K860152	MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY	Endo Lase, Inc.	1986-02-05	21
K855197	FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM	Laser Media	1986-01-21	26
K854027	LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM	Laserscope	1985-12-02	62
K843628	HOTIP HEMOSTATIC PROBE	Trimedyne, Inc.	1985-11-12	424
K852798	FIBERLASE 100 MEDICAL LASER SYSTEM	Laser Media	1985-07-29	28
K850509	ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM	Laser Media	1985-04-08	59
K850728	MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE	Cooper Lasersonics, Inc.	1985-04-08	45
K844460	ND. YAG LASER RECTAL PATHOLOGY	Endo Lase, Inc.	1985-01-16	62

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda