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Light Based Treatment For Cold Sores Herpes Simplex Virus-1

Page Type
Product Code
Definition
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Physical State
Uses a 1072nm +/- 12nm peak wavelength on a cold sore for a period of approximately 3 minutes. The power source is a standard alkaline 9v battery, which is replaceable. Treatment with the cold sore machine is commenced at the first symptoms of a cold sore and repeated every 12 hours until healing commences. The treatment area is approximately 7 sq cm. The device is activated by the ON button, and automatically powers down after the preprogrammed treatment time (approximately 3 minutes).
Technical Method
Applies low level light to a herpes simplex virus cold sore on the lips. The light shortens the healing time of the cold sore.
Target Area
Lips
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4860
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4860 Light based energy source device for topical application

§ 878.4860 Light based energy source device for topical application.

(a) Identification. The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.

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

(1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized.

(2) The cleaning and disinfection instructions for the device must be validated.

(3) The device must be demonstrated to be biocompatible.

(4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device.

(5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device.

(6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen.

(7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance.

(8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.

[83 FR 52969, Oct. 19, 2018]

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

Page Type
Product Code
Definition
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Physical State
Uses a 1072nm +/- 12nm peak wavelength on a cold sore for a period of approximately 3 minutes. The power source is a standard alkaline 9v battery, which is replaceable. Treatment with the cold sore machine is commenced at the first symptoms of a cold sore and repeated every 12 hours until healing commences. The treatment area is approximately 7 sq cm. The device is activated by the ON button, and automatically powers down after the preprogrammed treatment time (approximately 3 minutes).
Technical Method
Applies low level light to a herpes simplex virus cold sore on the lips. The light shortens the healing time of the cold sore.
Target Area
Lips
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4860
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4860 Light based energy source device for topical application

§ 878.4860 Light based energy source device for topical application.

(a) Identification. The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.

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

(1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized.

(2) The cleaning and disinfection instructions for the device must be validated.

(3) The device must be demonstrated to be biocompatible.

(4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device.

(5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device.

(6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen.

(7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance.

(8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.

[83 FR 52969, Oct. 19, 2018]