• FDA 510(k) records for OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 K984358
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FDA 510(k) K150907, Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, by Ellipse A/S

FDA 510(k) K150907, Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, by Ellipse A/S

$299.00 USD
$299.00 USD
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FDA 510(k) records for Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (K150907), submitted by Ellipse A/S.

  • 510(k) Number: K150907
  • Device Classification: Powered Laser Surgical Instrument
  • Applicant: Ellipse A/S
  • Date Received: 04/03/2015
  • Decision Date: 07/07/2015
  • Decision: Substantially Equivalent (SESE)
  • Regulation Number: 878.481
  • Product Code: GEX
  • Subsequent Product Code: ONF
  • Regulation Medical Specialty: General & Plastic Surgery
  • Review Panel: General & Plastic Surgery
  • Total Pages: 1634 (1507 unredacted, 7% redacted overall)

What's in this document (sections may appear in any order):

  • ~ 510(k) Summary / Statement: 40% redacted
  • ✗ Indications for Use: 80% redacted
  • ✗ Device Description: 75% redacted
  • ~ Substantial Equivalence / Predicate: 44% redacted
  • ✗ Performance / Bench Testing: 78% redacted
  • ✗ Biocompatibility: 66% redacted
  • ✓ Software / Cybersecurity: 15% redacted
  • ✗ Sterilization / Shelf Life: 92% redacted
  • ✗ Labeling / IFU: 61% redacted
  • ✗ Clinical Data: 83% redacted
  • ~ FDA Correspondence: 33% redacted
  • ✗ Risk Analysis / FMEA: 82% redacted
  • ✗ Electromagnetic Compatibility (EMC): 65% redacted

Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.

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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