FDA 510(k) K230013, Silk'n Titan Allways, by Silk'N Beauty , Ltd.

FDA 510(k) K230013, Silk'n Titan Allways, by Silk'N Beauty , Ltd.

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Device Classification Name: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
510(k) Number: K230013
Device Name: Silk'n Titan Allways
Applicant: Silk'N Beauty , Ltd.
Regulation Number: 878.442
Classification Product Code: PAY
Date Received: 2023-01-03
Decision Date: 2023-08-30
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 1,998
Fully redacted pages: 1,525
Content pages: 473

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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