# K030959: Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100

- Pathway: 510(k) (Special)
- Applicant: Laser Peripherals, LLC
- Decided: Apr 25, 2003 after 29 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
226 later devices descend from it; 1 cites it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050738: FT Fiber Optic Delivery Systems (2005), 225 descendants of its own
- 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

## Recalls of this device
- Jun 20, 2014 · Class II · Z-2073-2014: Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.

## Indications for use
The Laser Peripherals bare laser fiber is intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd:YAG, KTP and Diode lasers have been cleared.

Source page: https://510kreport.com/device/K030959
Methodology: https://510kreport.com/methodology