ADVATx
Basic Information
- Brand Name
- ADVATx
- Primary DI
- 05700002052209
- Version / Model
- 1.0
- Catalog Number
- 684
- Company Name
- Advalight ApS
- Labeler DUNS
- 310762054
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-18
- Public Version
- 4
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- fa3c3b0e-01f7-4207-81cc-e8e9d3598d49
Device Description
The laser system is for dermatological indications for use. The laser light is delivered to the patient through an applicator either a scanning hand piece or a single spot hand piece (optional). The ADVATx Laser System consists of a laser cabinet which houses the laser module, the user interface which allows the user to control the system and the laser delivery system. ADVATx does only come in one model. The laser does not use any consumables (besides standard power/electricity), and no accessories are offered. The ADVATx laser system is a Nd:YAG laser delivering 589nm Q-switched pulsed light and 1319nm continuous wave light. This laser has been developed specifically for dermatological (skin) treatments performed by healthcare professionals e.g. doctors.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 47877 | Dermatological frequency-doubled 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 to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700002052209 | GS1 | ||||
| Package | 05700002052216 | GS1 | colli | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +4546965412
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132976 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 150 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius