Primelase Excellence

High Technology Products S.L.U

Country / region:Spain (ES)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

1

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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    LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

    Lumenis, Ltd.

  • K172193

    Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules

    Alma Lasers, Inc.

  • K191321

    Primelase Excellence

    High Technology Products S.L.U

K201594 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K201594 as a predicate