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Title 21 Part 886 → Subpart B → §886.1395

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1395

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1395

e-CFR data is current as of June 13, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1395


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


§886.1395   Diagnostic Hruby fundus lens.

(a) Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.

(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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001]