(160 days)
The DK7786 handpiece is used in combination with the One Series™ Ultra Cartridge to fold and assist in inserting TECNIS® 1-Piece intraocular lenses. ONLY into the capsular bag.
Duckworth & Kent Ltd Model DK7786 Injector
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Duckworth & Kent Ltd. Injector DK 7786". This document does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The letter explicitly states that the device is a Class I product (KYB) and has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on a comparison to existing devices rather than a new clinical study with specific performance metrics.
Therefore, I cannot provide the requested information based on the input text. The prompt asks for details that are not present in this regulatory document.
§ 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.