FDA 510(k), K143120, OrthoPulse

FDA 510(k), K143120, OrthoPulse

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510(K) Number: K143120
Device Name: OrthoPulse
Manufacturer: BIOLUX RESEARCH LTD.
Device Classification Name: Orthodontic Led Accessory
Regulation Number: 872.5470
Classification Product Code: PLH
Date Received: 10/30/2014
Decision Date: 07/24/2015
Regulation Medical Specialty: Dental

Total pages: 1991
Fully redacted pages: 1844
Content pages: 147

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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