EXIRA

GUDID 08057017760979

The EXIRA is a medical laser equipped with: - Alexandrite 755 nm laser, that is a high power laser to remove hair and treat benign pigmented lesions effectively. The wavelength of 755nm is the most suitable for hair removal, especially for the skin types up to Fitzpatrick Type III, due to its high melanin absorption. Skin types more than III can be treated using a more careful procedure or Nd:YAG. - Nd:YAG 1064nm laser, that is a high power laser for effective treatments of vascular lesions and hair removal on all skin types. The wavelength of 1064nm is the most suitable fore removing vascular lesions, due to its high hemoglobin absorption capacity. The 1064nm wavelength has also good absorption in melanin, making the 1064nm the right hair removal solution for all types of skins. A suitable skin cooling system shall be used during laser treatments. The laser handpieces shall be used in conjuction with an external air cooling device.

EL.EN. SPA

Multi-modality skin surface treatment system

• Primary Device ID: 08057017760979
• NIH Device Record Key: cef9f85a-b156-453b-b58c-52b2b66dec23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXIRA
• Version Model Number: M126AC1
• Company DUNS: 436887608
• Company Name: EL.EN. SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057017760979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233090

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-24
• Device Publish Date: 2026-02-16

Devices Manufactured by EL.EN. SPA

• 08057017760979 - EXIRA: 2026-02-24The EXIRA is a medical laser equipped with: - Alexandrite 755 nm laser, that is a high power laser to remove hair and treat benign pigmented lesions effectively. The wavelength of 755nm is the most suitable for hair removal, especially for the skin types up to Fitzpatrick Type III, due to its high melanin absorption. Skin types more than III can be treated using a more careful procedure or Nd:YAG. - Nd:YAG 1064nm laser, that is a high power laser for effective treatments of vascular lesions and hair removal on all skin types. The wavelength of 1064nm is the most suitable fore removing vascular lesions, due to its high hemoglobin absorption capacity. The 1064nm wavelength has also good absorption in melanin, making the 1064nm the right hair removal solution for all types of skins. A suitable skin cooling system shall be used during laser treatments. The laser handpieces shall be used in conjuction with an external air cooling device.
• 08057017760979 - EXIRA: 2026-02-24 The EXIRA is a medical laser equipped with: - Alexandrite 755 nm laser, that is a high power laser to remove hair and treat beni
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