(106 days)
When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure. This injector will facilitate the insertion and proper placement of the ring in the capsular bag.
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The document you provided is a 510(k) clearance letter from the FDA for a medical device called "Capsule Tension Ring Inserter." This type of document declares substantial equivalence to a predicate device and does not typically include detailed information on acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance. These elements are usually found in study reports, clinical trial documentation, or more detailed regulatory submissions for devices requiring clinical evidence.
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§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.