# K050738: FT Fiber Optic Delivery Systems

- Pathway: 510(k) (Traditional)
- Applicant: Fibertech GmbH
- Decided: Jun 2, 2005 after 77 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904627 (1991). 34 ancestors in all.
225 later devices descend from it; 5 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923953: Megabeam, Ceram Optec, Inc. (1992) Summary page 2.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 2.
- K942182: Megabeam Dental Fiber, Ceram Optec, Inc. (1994) Summary page 2.
- K951775: Ceralas Diode Laser System (Model Ceralas D50), Ceram Optec, Inc. (1995) Summary page 2.
- K960413: Coherent Slimline Single Lumen Aspiration Needle Kit, Lumenis, Inc. (1996) Summary page 2.
- K960032: Coherent Versapulse Aesthetic Surgical Lasers, Coherent Medical Group (1996) Summary page 2.
- K991258: Novus Verdi Delivery Systems, Lumenis, Inc. (1999) Summary page 2.
- K994010: Innovaquartz General Shape Laser Fiber, Innovaquartz (1999) Summary page 2.
- K011207: Laser Peripherals Reusable Holmium Fiber, Laser Peripherals, LLC (2001)
- K030959: Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100, Laser Peripherals, LLC (2003) Summary page 2.
- K973172: Resposable Bare Fibers, Trimedyne, Inc. (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K092272: Randox Methadone Assay, Randox Laboratories, Ltd. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own

## Recalls of this device
- Oct 17, 2018 · Class II · Z-0579-2019: A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; howe
- Oct 17, 2018 · Class II · Z-0580-2019: A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; howe
- Oct 17, 2018 · Class II · Z-0581-2019: A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; howe
- Oct 17, 2018 · Class II · Z-0577-2019: A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; howe
- Oct 17, 2018 · Class II · Z-0578-2019: A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; howe

## Indications for use
The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Source page: https://510kreport.com/device/K050738
Methodology: https://510kreport.com/methodology