Manufacturer
A.R.C Laser GmbHWolf445nm
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
2SIROLaser Blue
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Not ingested
K192272 references 2 predicate/reference devices
Cited as predicate
3Fotona XPulse Pro Laser Platform
Leonardo Mini Blue
Deka Bluebeam
3 submissions cite K192272 as a predicate