21 CFR §884.6190

1. (a)Identification. Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes.
2. (b)Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.