# K202428: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Oct 22, 2020 after 58 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: 10 generations back to K936109 (1994). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201663: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories, Lumenis, Ltd. (2020) Summary page 4.

## Most influential descendants
- K212703: AcuPulse CO2 Laser System, Delivery Devices and Accessories (2021), 0 descendants of its own

## Indications for use
Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories 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 thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K202428
Methodology: https://510kreport.com/methodology