FDA 510K (K170984) LG BEAUTY LED MASK

FDA 510K (K170984) LG BEAUTY LED MASK

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Device Classification Name    Light Based Over The Counter Wrinkle Reduction
510(k) Number    K170984
Device Name    LG BEAUTY LED MASK
Applicant    LG Electronics
Regulation Number    878.4810
Classification Product Code     OHS  
Subsequent Product Code     OLP  
Date Received    04/03/2017
Decision Date    08/23/2017
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    General & Plastic Surgery

Total pages: 841
Fully redacted pages: 476
Content pages: 365

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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