# K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Dec 16, 2010 after 84 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: 18 generations back to K943450 (1995). 354 ancestors in all.
46 later devices descend from it; 2 cite it directly.
0 of 401 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100726: Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas HPD/ 980NM, Biolitec, Inc. (2010) Summary page 1.
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 1.

## Most influential descendants
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own
- K120810: Fiberoptic Laser Delivery System (2012), 24 descendants of its own
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K112253: Ceralas 147NM Diode Laser System (2011), 18 descendants of its own
- K152722: neoV980 & neoV1470 Diode Lasers (2015), 17 descendants of its own

## Indications for use
The Ceralas Fiber-Coupled 1470n 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. Added Indication for Use: Laser Assisted Lipolysis

Source page: https://510kreport.com/device/K102755
Methodology: https://510kreport.com/methodology