CFR
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886.1420—Ophthalmic lens gauge.
(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.
Code of Federal Regulations
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