Indications for Use:
The Capillus FOCAL MEDIAL 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.
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
The Capillus FOCAL MEDIAL 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 Capillus FOCAL MEDIAL; and may in fact cause a negative effect. Do not exceed
- Laser therapy should not be used in conjunction with medications or products
that are photosensitizing.
- Consult with your physician before using the Capillus FOCAL MEDIAL if; you have cancer of
the scalp; you are sensitive to light of 650 nm in wavelength.
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.
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.