FDA 510(k), K140336, OPTIMUS FUSION: SLT, YAG AND YAG/SLT

FDA 510(k), K140336, OPTIMUS FUSION: SLT, YAG AND YAG/SLT

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510(K) Number: K140336
Device Name: OPTIMUS FUSION: SLT, YAG AND YAG/SLT
Manufacturer:
Device Classification Name: Laser, Ophthalmic
Regulation Number: 886.4390
Classification Product Code: HQF
Date Received: 02/10/2014
Decision Date: 06/25/2014
Regulation Medical Specialty: Ophthalmic

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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