21 CFR § 886.4355
Corneal inlay inserter handle
June 25, 2020
(a) Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
(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.CITA>[84 FR 14870, Apr. 12, 2019]
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