FDA UDI
In Commercial Distribution
🇺🇸 United States
Solarc/SolRx 100-Series
DI: B219110UVB0
·
Model: 110UVB
·
Solarc Systems Inc
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solarc/SolRx 100-Series
- Primary DI
- B219110UVB0
- Version / Model
- 110UVB
- Company Name
- Solarc Systems Inc
- Labeler DUNS
- 256728031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 4
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- f7ef166d-a3a7-4d16-ae51-f6a4c1b7538f
Device Description
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-BROADBAND Handheld Device. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | General, Plastic Surgery | 878.4630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35149 | Ultraviolet phototherapy unit, professional | A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA). | No | Active |
| 34669 | Ultraviolet phototherapy unit, home-use | A mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B219110UVB0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061589 | 000 |