Back to free search
Home / Search / K133546

STARLITE-OM, LIGHT EFFECTS, THIBIANT

Ps Advanced Engineering · Class II · Cleared Aug 6, 2014

K-numberK133546
Device nameSTARLITE-OM, LIGHT EFFECTS, THIBIANT
ApplicantPs Advanced Engineering
Product codeOHS
Device classClass II
Decision dateAug 6, 2014
DecisionSubstantially Equivalent
Regulation878.4810
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 →

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

14-day free trial. No setup. Cancel anytime.

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 →