(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]