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Title 21 Part 886 → Subpart D → §886.3800

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart D → §886.3800

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart D → §886.3800

e-CFR data is current as of July 16, 2019

Title 21Chapter ISubchapter HPart 886Subpart D → §886.3800


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices


§886.3800   Scleral shell.

(a) Identification. A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]