Search Results
Found 1 results
510(k) Data Aggregation
K Number
K073352Device Name
WEBERNEEDLE BASIC LASER
Manufacturer
Date Cleared
2008-08-11
(256 days)
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
WEBER MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The weberneedle@basic laser is indicated to provide topical heating for the following:
- temporary increase of local blood circulation.
- temporary relief of minor muscle and joint aches, pains, and stiffness.
- temporary relaxation of muscles.
- temporary relief of muscle spasms.
- temporary relief of minor pain and stiffness associated with arthritis.
Device Description
The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.
Ask a Question
Ask a specific question about this device
Page 1 of 1