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
- 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—
—
Not ingested
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
InMode Diolaze System
K191321 references 3 predicate/reference devices
Cited as predicate
5MeDioStar
elysion-pro
Primelase Excellence
Eneka Pro
Diode Laser Therapy Systems (WLA-02)
5 submissions cite K191321 as a predicate
