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

Laserscope — Predicate Candidate Screening

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

90 daysmedian FDA review time

263 days90th percentile

60clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K062719	GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES	Laserscope	2006-12-01	80	4
K061646	LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE &	Laserscope	2006-06-27	15	0
K034011	GEMINI SURGICAL LASER SYSTEM & ACCESSORIES	Laserscope	2004-03-30	97	0
K024206	AURA ISURGICAL LASER SYSTEM & ACCESSORIES	Laserscope	2003-11-17	332	0
K020021	LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGUR	Laserscope	2002-07-02	180	0
K010834	LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES	Laserscope	2001-05-21	62	0
K010284	LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND	Laserscope	2001-05-01	90	3
K003765	LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND	Laserscope	2001-03-06	90	0
K003147	LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGU	Laserscope	2000-12-15	66	0
K990718	ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:Y	Laserscope	2000-03-08	370	0
K990903	LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONF	Laserscope	1999-08-27	162	0
K984424	AURA DYE LASER SYSTEM (ADLS)	Laserscope	1999-03-05	84	0
K984110	LASERSCOPE COOLSPOT	Laserscope	1998-12-18	31	0
K972575	800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER	Laserscope	1998-07-17	372	0
K974896	LASERSCOPE EL LASER SYSTEM AND ACCESSORIES	Laserscope	1998-03-27	86	0
K971843	LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES	Laserscope	1997-07-23	70	0
K971250	LASERSCOPE MICROBEAM IV MICROMANIPULATOR	Laserscope	1997-06-30	90	0
K964818	ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIG	Laserscope	1997-06-17	200	0
K970948	800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES	Laserscope	1997-05-21	68	0
K970157	LASERSCOPE AUTOMATIC EYE PROTECTION FILTER	Laserscope	1997-04-07	81	0
K964520	PARASCAN SCANNING DEVICE	Laserscope	1997-02-10	90	0
K964076	LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES	Laserscope	1997-01-08	89	0
K945614	ADD POWER FAMILY , MICRO ADDSTAT	Laserscope	1995-05-15	181	0
K951034	AURA LASER SYSTEM	Laserscope	1995-04-13	38	0
K950662	DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT	Laserscope	1995-03-10	25	0
K944977	COAXIAL ENDOSTAT	Laserscope	1994-11-08	28	0
K941841	SMARTSCAN	Laserscope	1994-08-15	124	0
K933880	SL SERIES SURGICAL LASER SYSTEMS	Laserscope	1994-02-25	199	0
K924720	VISIDISC KITS, SPINESCOPE	Laserscope	1993-10-08	382	0
K925130	NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)	Laserscope	1993-03-18	156	0
K924644	ENDOSTATS, MICROSTATS, ACCUSTATS	Laserscope	1993-02-23	162	0
K913990	KTP/532 & KTP/YAG	Laserscope	1992-09-02	363	0
K914918	LASERSCOPE'S MICROSPOT DERMASTAT	Laserscope	1992-07-24	263	0
K921380	LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER	Laserscope	1992-06-25	94	0
K920589	ANGLED DELIVERY DEVICE	Laserscope	1992-04-29	79	0
K920584	SCULPTURED ENDOSTAT	Laserscope	1992-04-10	60	0
K914518	KTP/YAG AND KTP/YAG PLUS	Laserscope	1992-04-02	176	0
K913758	KTP/532 AND KTP/YAG	Laserscope	1991-11-20	90	0
K914104	ENDOSTAT	Laserscope	1991-09-27	14	0
K912538	KTP/YAG PLUS	Laserscope	1991-09-06	88	0
K911830	LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER	Laserscope	1991-08-14	112	0
K912023	LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR	Laserscope	1991-06-11	35	0
K905424	KTP DISC KIT	Laserscope	1991-03-04	90	0
K902058	ADD'L USE OF THE KTP/YAG SURGICAL LASER	Laserscope	1990-06-29	53	0
K901943	KTP/532 (TM) SURGICAL LASER	Laserscope	1990-05-29	29	0
K895945	KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE	Laserscope	1990-04-09	180	0
K896183	KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY	Laserscope	1990-02-02	100	0
K884029	KTP/532 SURGICAL LASER	Laserscope	1988-11-25	63	0
K882734	KTP/YAG(TM) SURGICAL LASER	Laserscope	1988-09-09	70	0
K881788	KTP/532(TM) SURGICAL LASER	Laserscope	1988-06-27	62	0

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