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

Iridex Corp — Predicate Candidate Screening

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

90 daysmedian FDA review time

234 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K121475	TXCELL SCANNING LASER DELIVERY SYSTEM	Iridex Corp	2012-11-28	194
K071687	FAMILI OF IRIDEX IQ LASER SYSTEMS	Iridex Corp	2008-08-07	416
K062074	IRIDEX WIRELESS FOOTSWITCH	Iridex Corp	2006-11-14	116
K062369	IRIDEX OCULIGHT TX	Iridex Corp	2006-11-08	86
K060905	IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320	Iridex Corp	2006-05-31	58
K050562	OCULIGHT GL/GLX	Iridex Corp	2005-04-14	42
K040209	IRIS MEDICAL IQ 810 PHOTOCOAGULATOR	Iridex Corp	2004-09-20	234
K031665	IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS	Iridex Corp	2003-08-27	90
K022228	FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES	Iridex Corp	2002-10-08	90
K020849	APEX 800 LASER SYSTEM, MODEL APEX 800	Iridex Corp	2002-05-20	66
K020374	OCULIGHT SL/SLX	Iridex Corp	2002-05-03	88
K992298	IRIDERM, MODEL APEX 800	Iridex Corp	1999-12-09	154
K982031	OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE	Iridex Corp	1998-09-08	90

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