EXIRA
Basic Information
- Brand Name
- EXIRA
- Primary DI
- 08057017760979
- Version / Model
- M126AC1
- Company Name
- EL.EN. SPA
- Labeler DUNS
- 436887608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-16
- Public Version
- 1
- Public Version Date
- 2026-02-24
- Public Version Status
- New
- Public Device Record Key
- cef9f85a-b156-453b-b58c-52b2b66dec23
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45220 | Multi-modality skin surface treatment system | An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057017760979 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233090 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius