Identity
- Trade Name
- XTRAC FDA UDI
- Generic Name
- Dermatological excimer laser system FDA UDI
- Device Name
- Excimer Laser FDA UDI
- Model / Reference
- AL10000 FDA UDI
- Description
- Excimer Laser FDA UDI
Identifiers
- Primary DI / UDI-DI
- M709AL100000 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological excimer laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological excimer laser system
Xtrac by Strata Skin Sciences, inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological excimer laser system.
- Pharos — Catheter Precision, Inc · Class II
- PALLAS Service Manual — Laseroptek Co., Ltd · Class II
- PALLAS Service Manual — Laseroptek Co., Ltd · Class II
- PALLAS power cable — Laseroptek Co., Ltd · Class II
- PALLAS Handpiece — Laseroptek Co., Ltd · Class II
- PALLAS User Manual — Laseroptek Co., Ltd · Class II
- PALLAS Foot Switch — Laseroptek Co., Ltd · Class II
- PALLAS Arm — Laseroptek Co., Ltd · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Strata Skin Sciences, inc.
Sources (1)
- FDA UDI 9bd0e2d2-55bb-4bad-b56f-ff8d5db83eef 34 fields · synced May 30, 2026