MaxiFlex Fiber Optic Energy Delivery System
by Technology Delivery Systems, Inc.
510(k) K013300
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013300 | Date16 Apr 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The MaxiFlex Fiber Optic Energy Delivery System is a fiber optic device classified under 21 CFR 878.4810, designed for the delivery of laser energy. It facilitates soft tissue procedures including ablation, incision, excision, vaporization, and coagulation across general surgery, dermatology, intraoral, orthopaedic, maxillofacial, and cosmetic applications.
This system is intended for single-use in controlled clinical settings and requires compatibility with approved laser sources. Supplied sterile, it is regulated under FDA 510(k) clearance (K013300) and adheres to product code GEX. Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.
Other devices from Technology Delivery Systems, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of medical procedures can the MaxiFlex Fiber Optic Energy Delivery System be used for?
The MaxiFlex Fiber Optic Energy Delivery System is designed for soft tissue procedures across multiple specialties, including general surgery, dermatology, intraoral, orthopaedic, maxillofacial, and cosmetic applications. It facilitates laser-based actions like ablation, incision, excision, vaporization, and coagulation, depending on the compatible laser source used.
Is the MaxiFlex Fiber Optic Energy Delivery System intended for single-use or reusable applications?
The MaxiFlex Fiber Optic Energy Delivery System is explicitly intended for single-use in controlled clinical settings. This design ensures patient safety and maintains performance consistency, as reuse is not supported by the manufacturer.
How should the MaxiFlex Fiber Optic Energy Delivery System be stored to ensure sterility and functionality?
The system is supplied sterile, so storage must follow the manufacturer’s guidelines to preserve sterility and performance. Proper handling—such as keeping it in its original packaging, avoiding contamination, and adhering to recommended environmental conditions—is critical to maintaining its integrity for clinical use.
What laser sources is the MaxiFlex Fiber Optic Energy Delivery System compatible with?
The MaxiFlex Fiber Optic Energy Delivery System requires compatibility with approved laser sources to function effectively. While the specific laser types aren’t detailed here, the device is designed to work with standard laser systems used for soft tissue procedures, ensuring energy delivery for ablation, coagulation, or other intended actions.
How was the FDA clearance for the MaxiFlex Fiber Optic Energy Delivery System determined?
The MaxiFlex Fiber Optic Energy Delivery System received FDA clearance through a 510(k) submission (K013300), with a decision classification of *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, based on the manufacturer’s technical documentation and testing.