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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR886.4390]
 See Related Information on 886.4390 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 886 -- OPHTHALMIC DEVICES

Subpart E--Surgical Devices

Sec. 886.4390 Ophthalmic laser.

(a)Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

(b)Classification. Class II.
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