FDA 510(k), K123014, LITECURE THERAPY SYSTEM MODEL LTS-1500
FDA 510(k), K123014, LITECURE THERAPY SYSTEM MODEL LTS-1500
Device Name: LITECURE THERAPY SYSTEM MODEL LTS-1500
Manufacturer:
Device Classification Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Regulation Number: 878.4810
Classification Product Code: PDZ
Date Received: 09/27/2012
Decision Date: 03/29/2013
Regulation Medical Specialty: General & Plastic Surgery
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details