21 C.F.R. § 886.1420 Ophthalmic lens gauge.
Title 21 - Food and Drugs
(a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1420 Ophthalmic lens gauge.
