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

5

Device details

FDA 510(k) registration fields

K number
K191321
Device name
Primelase Excellence
Country / region
Spain(ES)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-05-15
Decision date
2019-08-02
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

Indications for use for PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include:
• 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

Indications for use for PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include: • 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 diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin. The PRIMELASE machine consists of a central unit and a set of 5 removable 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 applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The treatment can be provided in two modes, dynamic and static. Dynamic mode uses the low fluence & high frequency and is used for initial treatments. Static mode uses high fluence & low frequency and is used for residual hair removal. 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 05:55:22 UTC

Predicate devices

3

K191321 references 3 predicate/reference devices

Cited as predicate

5

5 submissions cite K191321 as a predicate