Manufacturer
High Technology Products S.L.UPrimelase Excellence
High Technology Products S.L.U
Country / Region:Spain (ES)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K201594
- Device name
- Primelase Excellence
- Country / Region
- Spain(ES)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-06-12
- Decision date
- 2020-12-17
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalPigment treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures. Indications for Use: PRIMELASE Excellence System with 810nm Laser applicator is intended for: - Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Treatment of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign pigmented lesions. PRIMELASE Excellence System with 755nm Laser applicator is intended for: - Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Treatment of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign pigmented lesions. PRIMELASE Excellence System with 1060nm Laser applicator is intended for: - Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Treatment of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, and other benign vascular lesions and leg veins. - Treatment of wrinkles. PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for: - Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. - Treatment of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI).
Intended Use
PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures. PRIMELASE Excellence System with 810nm Laser applicator is intended for: Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign pigmented lesions. PRIMELASE Excellence System with 755nm Laser applicator is intended for: Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign pigmented lesions. PRIMELASE Excellence System with 1060nm Laser applicator is intended for: Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI). Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, and other benign vascular lesions and leg veins. Treatment of wrinkles. PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for: Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI).
Device Description
PRIMELASE Excellence is a diode laser device which consists of a central unit and external applicators. The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 nm to 1060 nm, typically and most used 810 nm), pulsed through the laser aperture situated at the tip of the applicator. The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.
Summary parsed at:2026-06-01 05:48:19 UTC
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