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

Focus Medical, LLC — Predicate Candidate Screening

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

148 daysmedian FDA review time

434 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K152737	Lite Touch	Focus Medical, LLC	2016-06-29	280
K152529	NaturaLase CO2 Laser System	Focus Medical, LLC	2016-02-04	154
K151473	NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser	Focus Medical, LLC	2015-09-01	92
K110333	NATURALASE CO2 LASER SYSTEM	Focus Medical, LLC	2012-04-12	434
K101152	NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURA	Focus Medical, LLC	2010-08-18	117
K041829	FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUC	Focus Medical, LLC	2004-09-07	62
K032667	FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIE	Focus Medical, LLC	2004-01-23	148
K031828	NATURALASE LP ND:YAG LASER	Focus Medical, LLC	2003-07-17	34
K992597	LORAD LT-100 LASER TREATMENT SYSTEM	Focus Medical, LLC	2000-04-24	265

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