# K233344: Regenalase Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ipg Medical
- Decided: May 28, 2024 after 242 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: 21 generations back to K943450 (1995). 386 ancestors in all.
No later device cites it as a predicate yet.
0 of 387 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152722: neoV980 & neoV1470 Diode Lasers, G.N.S Neolaser, Ltd. (2015) Summary page 5.
- K133006: Neov Diode Laser Family, G.N.S Neolaser, Ltd. (2014) Summary page 6.

## Indications for use
1550nm laser: Indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including meniscus cartilage, in conjunction with an imaging modality for medical specialties including: General Surgery, Orthopedics, Podiatry, Arthroscopy and Spinal Surgery. 980nm laser: Indicated for use to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

Source page: https://510kreport.com/device/K233344
Methodology: https://510kreport.com/methodology