CapillusPlus S1

Indications for Use:

The CapillusPlus S1™ has been cleared by the Food and Drug Administration by a 510(k) for the treatment of androgenic alopecia (AGA) and promotion of hair growth in males who have Norwood Hamilton classifications of IIa-V patterns of hair loss; and in females who have Ludwig (Savin) Scale Class I through Class II or frontal patterns of hair loss; and both genders having Fitzpatrick Skin Types I to IV.

Shaded classifications below have been cleared by the US Food & Drug Administration for use of Capillus laser devices.

Fitzpatrick Classification of Skin Types: Low level laser therapy has only been tested on following Fitzpatrick skin types: TYPE 1: Highly sensitive, always burns, never tans. TYPE 2: Very sun sensitive, burns easily, tans minimally. TYPE 3: Sun sensitive skin, sometimes burns, slowly tans to light brown. TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown. Low level laser therapy has NOT been clinically tested on following Fitzpatrick skin types: TYPE 5: Sun insensitive skin, rarely burns, tans well. TYPE 6: Sun insensitive, never burns, deeply pigmented. LLLT at 650 nm and <5mW has never had any reported adverse effects for ANY skin tone, including the darkest of skin tones.

Regulatory Compliance:

Capillus, LLC lasers comply with 21 CFR 1040 for Class 3R Laser Products as administered by the Center for Device and Radiological Health of the US Food and Drug Administration and standard IEC60825 of the International Electrotechnical Commission.

Usage:

The CapillusPlus S1 should be used every day. The total time of each session is 6 minutes. Exceeding the recommended times or frequency will not increase the effect of the CapillusPlus S1; and may in fact cause a negative effect. Do not exceed recommended usage.

Precautions:

• Laser therapy should not be used in conjunction with medications or products that are photosensitizing.
• Consult with your physician before using the CapillusPlus S1 if; you have cancer of the scalp; you are sensitive to light of 650 nm in wavelength.

Sizing Information

Please note that our regular size caps fit most heads, with a head circumference of up to 24". If your head circumference is greater than 24" inches please contact customer service for ordering a larger size.

Safety Labels

Laser safety is the safe design, use and implementation of lasers to minimize the risk of laser accidents, especially those involving eye injuries. To control the risk of injury, various specifications define “classes” of laser depending on their power and characteristics.

Laser