# K073063: 15W Ceralas D 1470NM Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Feb 27, 2008 after 120 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: 10 generations back to K910422 (1992). 258 ancestors in all.
202 later devices descend from it; 7 cite it directly.
0 of 461 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040921: Cooltouch, Model NS 160, Cooltouch, Inc. (2004) 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.
- K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1.

## Most influential descendants
- 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
- 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

## 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/K073063
Methodology: https://510kreport.com/methodology