21 CFR 884.6200 - Assisted reproduction laser system.

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§ 884.6200 Assisted reproduction laser system.

(a)Identification. The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

(b)Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.

[ 69 FR 77624, Dec. 28, 2004]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 884 after this date.

  • 2018-06-05; vol. 83 # 108 - Tuesday, June 5, 2018
    1. 83 FR 25910 - Medical Devices; Exemptions From Premarket Notification: Class II Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective June 5, 2018.
      21 CFR Parts 862, 866, 876, 880, and 884