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Medilas H RFID Laser Fibers

Dornier Medtech America, Inc.

Country / Region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

Dornier Medtech America, Inc. logoDornier Medtech America, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K152591
Device name
Medilas H RFID Laser Fibers
Company
Dornier Medtech America, Inc.
Country / Region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-09-10
Decision date
2015-10-08
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

- Arthroscopy
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT
- General Surgery

Intended Use

Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ('Laser'). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery.

Device Description

The Dornier's Medilas H RFID Laser Fiber has the same technological characteristics and principles of operation as the predicate device.

Summary parsed at:2026-06-01 06:11:40 UTC

Predicate devices

2

K152591 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K152591 as a predicate