# K100726: Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas HPD/ 980NM

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Sep 15, 2010 after 184 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: 17 generations back to K943450 (1995). 329 ancestors in all.
54 later devices descend from it; 3 cite it directly.
0 of 384 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072682: 50W Ceralas D 1950NM Diode Laser, Biolitec, Inc. (2008) Summary page 1.
- K002296: Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15, Ceram Optec, Inc. (2000) Summary page 1.
- K083613: Quanta System Polysurge Diode Laser Family, Quanta System Spa (2008) Summary page 1.
- K072034: Diode Medical Laser Family, Models 4, 6, 30, Quanta System Spa (2007) Summary page 1.
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene, Intermedic Arfran, SA (2006) Summary page 1.
- (no number) Quanta System Model 30 (808nm & 940nm) laser family: named in the summary without a submission number

## Most influential descendants
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- 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

## Indications for use
The Ceralas Fiber-Coupled Diode Laser family 9S0nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cuffing, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endloscopic 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. Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Source page: https://510kreport.com/device/K100726
Methodology: https://510kreport.com/methodology