Name: Predicase
Price: 199 USD

K-number	K220467
Device name	The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Applicant	Lumenis Be, Ltd.
Product code	GEX
Device class	Class II
Decision date	May 18, 2022
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 →

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories

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