E-One Clinic RC

Organization name

E-SWIN SAS

SRN

FR-MF-000011807

Manufacturer status

Active

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• CW999

  Conditions of age: 12 years and with prior agreement of legal representatives for minors ✓ Pregnant women ✓ On black skin (phonotype VI and superior) ✓ Skin recovering from sunburn within the previous month ✓ Previous history of sun allergy ✓ Skin exposed to high pressure artificial UV fewer than 10 days before ✓ Use of tanning products (cream or dietary supplements) on the area to be treated within the previous 2 weeks ✓ Use of tan activators ✓ Injured, burnt, or infected skin ✓ Unusual skin lesions (medical advice should be sought) ✓ People suffering from a skin condition (eczema, inflammation, acne, etc) ✓ Eyelids with permanent make-up ✓ People undergoing a photosensibilising treatment (depending on medical advice, these patients may not be accepted for treatment with E>One) Previous history of skin disease ✓ People with diabetes, haemophilia, epilepsy, porphyria cutanea tarda ✓ People fitted with a cardiac pacemaker or defibrillator Also pay attention to: ✓ High-risk areas (blemishes, birthmarks, warts, unhealed wounds...), ✓ Moles (if they’re located in the zone to be treated, they must first be protected, for example by covering them with the self-adhesive patches provided with your device) ✓ Tattooed areas, permanent make-up (e.g. eyelids) or cosmetic tattoos, regardless of their colour. If this is the case, use the delimitation stop plate supplied with your device. ✓ Make-up: all traces of make-up must be removed before starting the treatment

Primary placement in France; available across 30 countries total.

Trade name

E-One Clinic RC

UDI-DI code

D-3662824ZT

Basic UDI-DI

B-3662824ZT

Reference / catalog number

D002AF004Bxxx

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The D002AF004BXXX is an active medical device using Intense Regulated Pulse Light IRPL® (frequency wavelengths) to treat excess of hair associated with hormonal or idiopathic hirsutism, and for depilation for purely aesthetic purposes on all parts of the body, excluding the peri-ocular region.

Additional information URL

https://esw-beauty.com/

Clinical sizes

No clinical sizes registered for this device.

• X0502HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT

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