(a) Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.
(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 Sec. 886.9. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001]