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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR886.5201]
See Related Information on Intense pulsed light device for managing dry eye. 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 F - Therapeutic Devices

Sec. 886.5201 Intense pulsed light device for managing dry eye.

(a) Identification. An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate adverse events and improvement of dry eye signs and symptoms under anticipated conditions of use.

(2) Thermal safety assessment in a worst-case scenario must be performed to validate temperature safeguards.

(3) Performance testing must demonstrate electrical safety and electromagnetic compatibility (EMC) of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Physician and patient labeling must include:

(i) Device technical parameters;

(ii) A summary of the clinical performance testing conducted with the device;

(iii) A description of the intended treatment area location;

(iv) Warnings and instructions regarding the use of safety-protective eyewear for patient and device operator;

(v) A description of intense pulse light (IPL) radiation hazards and protection for patient and operator;

(vi) Instructions for use, including an explanation of all user interface components; and

(vii) Instructions on how to clean and maintain the device and its components.

[88 FR 3638, Jan. 20, 2023]

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