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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- HJFMagnifier, Hand-Held, Low-Vision1Product Code
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- HKBTelescope, Hand-Held, Low-Vision1Product Code
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- HPEAid, Vision, Optical, Battery-Powered1Product Code
- HPFAid, Vision, Electronic, Ac-Powered1Product Code
- HPGAid, Vision, Electronic, Battery-Powered1Product Code
- HPIAid, Vision, Optical, Ac-Powered1Product Code
- HQDLens, Contact (Other Material) - Daily2Product Code
- HQGLens, Spectacle, Non-Custom (Prescription)1Product Code
- HQYSunglasses (Non-Prescription Including Photosensitive)1Product Code
- HQZFrame, Spectacle1Product Code
- HRCSterilizer, Soft-Lens, Thermal, Battery-Powered2Product Code
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered2Product Code
- HRLUnit, Beta, Radiation, Ophthalmic2Product Code
- KYEInserter/Remover Contact Lens1Product Code
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- MWLLens, Contact (Rigid Gas Permeable), Extended Wear3Product Code
- MZDSystem, In-Office Tinting, Contact Lenses2Product Code
- NAILens, Prescription, Color Deficiency1Product Code
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- ORZEyelid Thermal Pulsation System2Product Code
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- PLXTear Duct Occluder1Product Code
- PQJIntranasal Electrostimulation Device2Product Code
- QBRIntranasal Electrostimulation Device For Dry Eye Symptoms2Product Code
- QIUIntense Pulsed Light Device For Managing Dry Eye2Product Code
- QKVElectromechanical Tear Stimulator2Product Code
- QMMHydrophilic Re-Coating Solution2Product Code
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Intense Pulsed Light Device For Managing Dry Eye
- Page Type
- Product Code
- Definition
- 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.
- Physical State
- IPL applicator.
- Technical Method
- Intense pulsed light (IPL) applicator is a high-powered, hand-held flashgun to deliver an intense, visible, broad-spectrum pulse of light that targets specific structures and chromophores (e.g., melanin in hair, or oxyhemoglobin in blood vessels) that are heated to destruction and reabsorbed by the body.
- Target Area
- Malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear).
- Regulation Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 886.5201
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 886.5201 Intense pulsed light device for managing dry eye
§ 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]