Manufacturer
Heager GmbHHeager Medical Laser Family (Sabrina/Adolf)
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250261
- Device name
- Heager Medical Laser Family (Sabrina/Adolf)
- Company
- Heager GmbH
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-29
- Decision date
- 2025-08-26
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatmentOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Intended Use
The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Device Description
The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Heager Medical Laser Family has following characteristics: Dual wavelengths, Temperature monitoring system.
Summary parsed at:2026-06-01 05:22:21 UTC
Predicate devices
3—
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Not ingested
Diode laser therapy device
Medical Diode Laser (Model: L2)
K250261 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250261 as a predicate
