Name: Predicase
Price: 199 USD

K-number	K230990
Device name	Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
Applicant	Candela Corporation
Product code	GEX
Device class	Class II
Decision date	Jun 1, 2023
Decision	Substantially Equivalent
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 →

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

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