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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.

The Lazr Pulsr 4x is a non-heating lamp, infrared as described under the provisions of 21 CFR 890.5500.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Lazr Pulsr 4x" device does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a standard FDA clearance letter, which primarily:

• Confirms that the FDA has reviewed the 510(k) premarket notification.
• States that the device is "substantially equivalent" to predicate devices.
• Provides the regulation number, name, and product code.
• Informs the manufacturer about general controls, additional regulations, and their responsibilities under the Act.
• Includes an "Indications for Use" statement.

Therefore, I cannot provide the requested information based on this input. To answer your questions, I would need a different document, such as the actual 510(k) summary, clinical study reports, or a performance testing report that would detail the scientific and technical basis for the device's substantial equivalence.

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