Search Results
Found 1 results
510(k) Data Aggregation
K Number
K083560Device Name
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
Manufacturer
Date Cleared
2008-12-11
(9 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LIGHTHOUSE TECHNICAL INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Expanded Spectrum Photo Therapy Device (ESPT-3X) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:
- the temporary relief of minor muscle and joint pain and stiffness, .
- minor arthritis pain, .
- muscle spasm, 0
- the temporary increase in local blood circulation and/or .
- promoting relaxation of muscle. .
The ESPT-3X is for prescription use only.
Device Description
The ESPT-3X console is a non-invasive, portable, therapeutic medical laser designed to deliver high level (Class IV) energy/power for the purpose of reducing musculoskeletal pain. A "hand piece" accessory evenly delivers a Class IV laser to the target tissue. This channel is equipped with a red aiming beam (1 mW) that provides visible illumination of the area being treated. The console is equipped with a separate and independent timer that is manually set by the operator.
Ask a Question
Ask a specific question about this device
Page 1 of 1