Name: Predicase
Price: 199 USD

K-number	K870517
Device name	0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE
Applicant	Coherent Medical Group
Product code	GEX
Device class	Class II
Decision date	Apr 10, 1987
Decision	Substantially Equivalent for Some Indications
Regulation	878.4810

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 →

0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE

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