# K112324: Ceralas 980NM Diode Laser Family

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Sep 6, 2011 after 25 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
No predicates in its family tree.
25 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ceralas 980nm Diode Laser Family: named in the summary without a submission number

## Most influential descendants
- K152722: neoV980 & neoV1470 Diode Lasers (2015), 17 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K112013: Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser (2012), 6 descendants of its own
- K240747: Medical Diode Laser (M2-GK) (2024), 4 descendants of its own
- K120231: Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) (2012), 4 descendants of its own

## Indications for use
The Ceralas Fiber-Coupled 980nm 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. Indications include: General Surgery, Urology, Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery! Peripheral, Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis, Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.

Source page: https://510kreport.com/device/K112324
Methodology: https://510kreport.com/methodology