# K981438: Dornier Medilas E

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Surgical Products, Inc.
- Decided: Jul 20, 1998 after 90 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: 4 generations back to K954013 (1996). 8 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971404: Schwartz Electro-Optics, Inc.  CLR 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1997). Our OCR of the scanned summary read K871404, FDA’s number for Kultsure (Ncs Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser”. Summary page 1.
- K974039: Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase, Schwartz Electro-Optics, Inc. (1998) Summary page 1.
- K971648: Sharplan Erbium: Yag Laser (4020), Sharplan Lasers, Inc. (1997) Summary page 1.

## Most influential descendants
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own

## Indications for use
The Dornler Medilas E Laser is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Dornier Medilas E may also be used for skin resurfacing. The Dornier Medilas E is indicated for use in medicine and surgery, in the following medical specialties: ¢ Demnatology ¢ Gastroenterology ¢ Plastic Surgery ¢ ENT ¢ General Surgery ¢ Thoracic Surgery ¢ Urology ¢ Oral & Maxillofacial Surgery ¢ Gynecology ¢ Ophthalmology ¢ Pulmonary Surgery ¢ Podiatry

Source page: https://510kreport.com/device/K981438
Methodology: https://510kreport.com/methodology