(185 days)
The Nova-New Lens Re-hydrophilization System is indicated for use for the in-office only re-hydrophilization of NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses for daily wear. The Nova-New Lens Re-hydrophilization System permits the eye care practitioner to modify the surface of the contact lens.
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§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.