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

Laser Peripherals, LLC — Predicate Candidate Screening

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

74 daysmedian FDA review time

122 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170366	Laser Peripherals, LLC Family of Bare Laser Fibers	Laser Peripherals, LLC	2017-06-08	122	0
K030959	BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-60	Laser Peripherals, LLC	2003-04-25	29	1
K011207	LASER PERIPHERALS REUSABLE HOLMIUM FIBER	Laser Peripherals, LLC	2001-07-24	96	0
K992083	SCATTERFREE LATERAL EMITTING FIBER	Laser Peripherals, LLC	1999-07-12	21	0
K974229	LS-905 FIBERCHOICE ADAPTER SYSTEM	Laser Peripherals, LLC	1998-02-10	90	0
K972272	LASER PERIPHERALS HOLMIUM BARE FIBERS	Laser Peripherals, LLC	1997-07-29	41	0
K961516	LASER PERIPHERALS INC. BARE FIBER	Laser Peripherals, LLC	1996-06-27	66	0
K961079	LASER PERIPHERALS INC. SCATTERFREE FIBER	Laser Peripherals, LLC	1996-05-22	65	0
K901786	LASEGUIDE CAT # CLF-600D & CLF-1000D	Laser Peripherals, LLC	1990-06-27	70	0
K880591	LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE	Laser Peripherals, LLC	1988-06-01	111	0
K880592	LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE	Laser Peripherals, LLC	1988-04-25	74	0
K874680	LASEGUIDE 600A, 600B, 400A, AND 400B	Laser Peripherals, LLC	1988-03-23	131	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