Identity
- Trade Name
- QuRAS Collimation H/P FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- QND Collimation H/P FDA UDI
- Model / Reference
- QND Collimation H/P FDA UDI
- Description
- QND Collimation H/P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800023200270 FDA UDI
- 510(k) Number
- K173038 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological frequency-doubled solid-state 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
Yes
FDA UDI
Category: Dermatological frequency-doubled solid-state laser system
QuRAS Collimation H/P by Ilooda.co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173038 also covers:
- CuRAS Articulated Arm — CLASSYS Inc.
- CuRAS Collimation Handpiece — CLASSYS Inc.
- CuRAS Collimation MLA Handpiece — CLASSYS Inc.
- CuRAS Fractional Handpiece — CLASSYS Inc.
- CuRAS Main Unit — CLASSYS Inc.
- CuRAS Set Package — CLASSYS Inc.
- CuRAS Zoom Handpiece — CLASSYS Inc.
- CuRAS Zoom MLA Handpiece — CLASSYS Inc.
- CuRAS Articulated Arm — ILOODA.CO., LTD
- CuRAS Collimation H/P — ILOODA.CO., LTD
- CuRAS Fractional H/P — ILOODA.CO., LTD
- CuRAS Main Head — ILOODA.CO., LTD
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 |
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Manufacturer
- Manufacturer
- Ilooda.co., Ltd
Sources (1)
- FDA UDI 323b08d9-3ae3-4a74-980f-9d2f1981e4a2 35 fields · synced May 30, 2026