StacksVerified U.S. regulatory reference

21 CFR §886.3340

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
  2. (b)Classification. Class II.