Atlas FDA

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

Litecure, LLC — Predicate Candidate Screening

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

66 daysmedian FDA review time
223 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC2018-02-221460
K123014LITECURE THERAPY SYSTEM MODEL LTS-1500Litecure, LLC2013-03-291830
K123031BWF-5 MEDICAL LASER SERIESLitecure, LLC2012-12-03660
K121487LITECURE THERAPY COMPACTLitecure, LLC2012-06-12250
K103511LITECURE THERAPY SYSTEMLitecure, LLC2011-01-25560
K093087BWF-5 MEDICAL LASER SERIESLitecure, LLC2010-05-122230
K070400LC THERAPY, MODEL LCT-1000Litecure, LLC2007-02-28160

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