(63 days)
For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses
Not Found
The provided document is a 510(k) premarket notification decision letter from the FDA to UNILENS Corporation, USA. It concerns the conversion of soft (hydrophilic) daily wear contact lenses to parametric release from moist heat sterilization.
This document does not contain the information requested regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter acknowledges the submission and clarifies regulatory aspects but does not include the detailed study results or performance metrics one would expect in a clinical study report or verification and validation documentation. It lists numerous previously cleared products and their approval numbers but does not delve into the studies supporting the parametric release change.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.