Manufacturer
Endymed Medical, Ltd.PURE Laser
Country / Region:Israel (IL)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K222369
- Device name
- PURE Laser
- Company
- Endymed Medical, Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-08-05
- Decision date
- 2022-10-07
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
Indications for use for the Pure Laser diode hair removal system with a 810nm applicator 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 regimen. • Treatment of Pseudo folliculitis Barbae (PFB) • Use on all skin types (Fitzpatrick I-VI)
Intended Use
Indications for use for the Pure Laser diode hair removal system with a 810nm applicator 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 regimen. Treatment of Pseudo folliculitis Barbae (PFB). Use on all skin types (Fitzpatrick I-VI).
Device Description
The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI). The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).
Summary parsed at:2026-06-01 05:40:20 UTC
Predicate devices
2—
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Not ingested
elysion-pro
K222369 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K222369 as a predicate
