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Wolf445nm

A.R.C Laser GmbH

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

A.R.C Laser GmbH
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

3
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Device details

FDA 510(k) registration fields

K number
K192272
Device name
Wolf445nm
Company
A.R.C Laser GmbH
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-08-22
Decision date
2020-03-17
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Intended Use

The Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Device Description

The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm. The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.

Summary parsed at:2026-06-01 05:46:49 UTC

Predicate devices

2

K192272 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K192272 as a predicate