# K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470

- Pathway: 510(k) (Special)
- Applicant: Biolitec, Inc.
- Decided: Dec 3, 2008 after 119 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: 1 generation back to K043046 (2005). 4 ancestors in all.
128 later devices descend from it; 5 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043046: Cooltouch, Model CT3S, New Star Lasers, Inc. (2005) Summary page 1.
- K051434: Cooltouch ND:Yag Laser Systems, Models CT3S and Ctev, New Star Lasers, Inc. (2005) Summary page 1.
- K061618: Cooltouch, Model Ctev, New Star Lasers, Inc. (2006) Summary page 1.
- K062210: Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160, New Star Lasers, Inc. (2006) Summary page 1.
- (no number) Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470): named in the summary without a submission number

## Most influential descendants
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own

## Indications for use
The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K082225
Methodology: https://510kreport.com/methodology