# K232133: Co2 Laser System, Models: PureLase And VanLase

- Pathway: 510(k) (Traditional)
- Applicant: Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
- Decided: Apr 16, 2024 after 273 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 357 ancestors in all.
No later device cites it as a predicate yet.
0 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162169: EdgeOne CO2 Laser, Jeisys Medical, Inc. (2016) Summary page 5.

## Indications for use
CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K232133
Methodology: https://510kreport.com/methodology