Ópphalo LS-3000

Organization name

COMERCIAL COSMETICA VALLADOLID S.L.

SRN

ES-MF-000000631

Manufacturer status

Active

8 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Read User Manual before use.
• CW261

  EUDAMED did not publish a description for this code.
• CW013

  Laser product Class IV.
• CW014

  EUDAMED did not publish a description for this code.
• CW167

  Mandatory the use of protective eyewear complies with EN 207:2017-05 for its wavelength
• CW084

  Protective eyewear is mandatory for all users in the room. A sign warning of the Class IV laser hazard is required in the room.
• CW007

  EUDAMED did not publish a description for this code.
• CW018

  Consult contraindications in the User Manual before use. Do not use on patients with photosensitizing medication, active skin conditions, pregnancy, or implanted electronic devices.

Primary placement in Spain; available across 11 countries total.

Trade name

Ópphalo LS-3000

UDI-DI code

08437023998021

Basic UDI-DI

8437023998LS-3000D4

Reference / catalog number

LS-3000

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Progressive and long-term reduction of hair through selective photothermolysis (aesthetic use, non-medical purpose)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12040201PHOTOEPILATION EQUIPMENT