# K013300: Maxiflex Fiber Optic Energy Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Technology Delivery Systems, Inc.
- Decided: Apr 16, 2002 after 195 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) StrateFire: named in the summary without a submission number
- (no number) InnovaQuartz SE: named in the summary without a submission number

## Most influential descendants
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own

## Indications for use
The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver laser energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and cosmetic surgery. The MaxiFlex fiber is intended for energy delivery for ablating, incising, excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system. The device is suitable for use for all applications for which the laser output unit is 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/K013300
Methodology: https://510kreport.com/methodology