FDA UDI
In Commercial Distribution
🇺🇸 United States
RevoLix HTL
DI: 04250341911695
·
Model: 105 401 010
·
LISA Laser Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RevoLix HTL
- Primary DI
- 04250341911695
- Version / Model
- 105 401 010
- Company Name
- LISA Laser Products GmbH
- Labeler DUNS
- 315026396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-04
- Public Version
- 1
- Public Version Date
- 2024-04-12
- Public Version Status
- New
- Public Device Record Key
- fb583a94-686e-43f9-b9d3-b26924ed2840
Device Description
The RevoLix HTL laser device is a Thulium-YAG laser and emits radiation of the wavelength 2013 nm (±10 nm) (equivalent to approx. 2 µm). The wavelengths of the laser radiation are in the invisible infrared range. The RevoLix HTL laser device offers a combination of two operating modes. In CW operation (CW), the emission of laser radiation is continuous (continuous wave). In pulsed mode (PULSE or QCW) the radiation is repeatedly emitted at an adjustable frequency. In pulsed mode, the peak power of the individual pulses is higher than the average power
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 36170 | General/multiple surgical solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250341911695 | GS1 |
Customer Contacts
- Phone
- +49555699380
- [email protected]