K-number	K031665
Device name	IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
Applicant	Iridex Corp
Product code	HQF
Device class	Class II
Decision date	Aug 27, 2003
Decision	Substantially Equivalent
Regulation	886.4390

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS

Everything you need for a 510(k) submission. Nothing you don't.