FDA UDI
In Commercial Distribution
🇺🇸 United States
Pharos
DI: 00842362100017
·
Model: EX-308
·
RA MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pharos
- Primary DI
- 00842362100017
- Version / Model
- EX-308
- Company Name
- RA MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 131845013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-04
- Public Version
- 4
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- f343b5c6-9d5f-40ee-8b79-2df3fb966c1a
Device Description
A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma
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 |
|---|---|---|---|---|
| 47882 | Dermatological excimer laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power ultraviolet laser beam (UVA and/or UVB) intended for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842362100017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062963 | 000 |