7. HEALITE II TM
畛 xuy棚n x但u cu畉 t畛ng b動畛c s坦ng
~ upper middermis
~ deep dermis
8. MULTIPLE WAVELENGTHS &
COMBINATION
HEALITE
HEALITE IITM Combo
IITM
830 (w/ 590)
830 (w/ 590) + 633
633
633 + 415
415
415 + 830 (w/ 590)
HEALITE IITM
830 nm (+ 590 nm) FDA 510(k) cleared.
633 nm and 415 nm are not cleared by FDA.
830 nm (+ 590 nm), 633 nm, 41 5nm are all CE cleared.
2/20/2014
HEALITE IITM Combo
No FDA nor CE
COMPANY CONFIDENTIAL - DO NOT DISTRIBUTE
9. INDICATIONS
830 nm with 590 nm
633 nm
415 nm
photosequencing
Wound Healing
Pain Relief
Hair Regrowth
Acne Treatment
Skin Rejuvenation
Exogenous PDT with 5-ALA
Skin Rejuvenation
Hair Regrowth
HEALITE IITM
830 nm (+ 590 nm) FDA 510(k) cleared.
633 nm and 415 nm are not cleared by FDA.
830 nm (+ 590 nm), 633 nm, 41 5nm are all CE cleared.
HEALITE IITM Combo
No FDA nor CE
Active Acne
Endogenous PDT
(Kill P.acne)
Above indications are general indications only.
For specific indications cleared or approved by either FDA or CE, refer below.
HEALITE II TM FDA for :
Temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving
stiffness; promoting the relaxation of muscle tissue and to temporarily increase local
blood circulation where applied.
HEALITE II TM CE for :
Wound healing, Skin rejuvenation, Pain relief, Acne treatment
2/20/2014
COMPANY CONFIDENTIAL - DO NOT DISTRIBUTE
10. INDICATIONS
Adjunctive Therapy
Accelerates wound healing post laser or post
surgery
Reduces pain, bruising, edema and erythema
Offers prophylaxis against scar formation
Reduces PIH
Improves the clinical results
2/20/2014
COMPANY CONFIDENTIAL - DO NOT DISTRIBUTE