# K090281: Accutech Family of Powerflex Laser Delivery Devices

- Pathway: 510(k) (Traditional)
- Applicant: Accutech Medical Technologies, Inc.
- Decided: Mar 4, 2009 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: 6 generations back to K894841 (1989). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061025: Accutech Endolite Probe, Accutech Medical Technologies, Inc. (2006) Summary page 1.
- K073496: Optilite Holmium Laser Fibers, Cook Urological, Inc. (2008) Summary page 1.
- K050738: FT Fiber Optic Delivery Systems, Fibertech GmbH (2005) Summary page 1.
- K013300: Maxiflex Fiber Optic Energy Delivery System, Technology Delivery Systems, Inc. (2002)

## Indications for use
The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

Source page: https://510kreport.com/device/K090281
Methodology: https://510kreport.com/methodology