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510(k) Data Aggregation
K Number
K041565Device Name
LAZRPULSR 4X
Manufacturer
LED HEALING LIGHT LLC
Date Cleared
2005-03-03
(266 days)
Product Code
NHN
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LED HEALING LIGHT LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lazr Pulsr 4x is a non-heating lamp, infrared as described under the provisions of 21 CFR 890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Device Description
The Lazr Pulsr 4x is a non-heating lamp, infrared as described under the provisions of 21 CFR 890.5500.
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