# K112253: Ceralas 147NM Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Sep 20, 2011 after 46 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: 19 generations back to K943450 (1995). 356 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073063: 15W Ceralas D 1470NM Diode Laser, Biolitec, Inc. (2008) Summary page 1.
- K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470, Biolitec, Inc. (2008) Summary page 1.
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser, Biolitec, Inc. (2010) Summary page 1.

## Most influential descendants
- K152722: neoV980 & neoV1470 Diode Lasers (2015), 17 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K240747: Medical Diode Laser (M2-GK) (2024), 4 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240644: Medical Diode Laser (S1Pro) (2024), 2 descendants of its own

## Indications for use
The Ceralas Fiber-Coupled 1470nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection,, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

Source page: https://510kreport.com/device/K112253
Methodology: https://510kreport.com/methodology