# K201663: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Jul 16, 2020 after 27 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: 9 generations back to K936109 (1994). 29 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K180597: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO, Lumenis, Ltd. (2018) Summary page 4.

## Most influential descendants
- K202428: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (2020), 1 descendant of its own
- 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/K201663
Methodology: https://510kreport.com/methodology