FDA UDI
In Commercial Distribution
🇺🇸 United States
VTRAC
DI: M709VTRAC01
·
Model: VTRAC
·
Strata Skin Sciences, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VTRAC
- Primary DI
- M709VTRAC01
- Version / Model
- VTRAC
- Company Name
- Strata Skin Sciences, Inc.
- Labeler DUNS
- 618522536
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-06
- Public Version
- 1
- Public Version Date
- 2025-03-14
- Public Version Status
- New
- Public Device Record Key
- 67fe622c-dc32-4a3d-8c86-57cca5b863fc
Device Description
Excimer Lamp Phototherapy System
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 Unsafe
- 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 |
|---|---|---|---|---|
| 67337 | Free-standing multi-speciality photodynamic therapy/phototherapy unit | A freestanding electrically-powered device designed to emit visible light to the skin for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as non-melanoma skin cancer, and for phototherapy applications (e.g., psoriasis, hypertension, diabetes, attention deficit) associated with many clinical specialties (e.g., musculoskeletal, cardiovascular, neurology, pulmonology, dermatology). It is a large chamber lined with light-emitting diodes (LED) and features a diagnostic module to monitor parameters (e.g. blood pressure, respiratory rate) and provide real-time feedback to inform treatment; It is intended for use by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M709VTRAC01 | HIBCC |
Customer Contacts
- Phone
- 7606023300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051428 | 000 |