Identifiers
- 510(k) Number
- K871871 FDA 510(k)
- FDA Product Code
- HQE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4150 FDA 510(k)
- Regulation Number
- 886.4150 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Series Ten Thousand Ocutome is an AC-powered instrument designed for vitreous aspiration and cutting. It functions as an ophthalmic device used to perform surgical procedures involving the vitreous body of the eye.
This device is identified under FDA 510(k) clearance K871871. It is categorized as a class 2 medical device under regulation number 886.4150.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K871871 - Series Ten Thousand Ocutome, SERIES TEN THOUSAND OCUTOME (K871871) — FDA 510(k) | Innolitics, Series Ten Thousand Ocutome 510 (k) FDA Premarket Notification K871871 ..., D352106 - image-ppubs.uspto.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K871871 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K871871 24 fields · synced Sep 24, 2026