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Title 21 Part 886 → Subpart B → §886.1340

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1340

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1340

e-CFR data is current as of September 19, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1340


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§886.1340   Haploscope.

(a) Identification. A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).

(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.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001]