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Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Model / Reference
- JK 155 / 46-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EJKP100003271A0 FDA UDI
- 510(k) Number
- K151400 FDA UDI
- FDA Product Code
- LEJ FDA UDI
- GMDN Term
- Ultraviolet tanning device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4635 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
No
FDA UDI
Over-the-Counter
Yes
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: Ultraviolet tanning device
Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY by JK-Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultraviolet tanning device.
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Cleared under the same submission
K151400 also covers:
- Ergoline Affinity 500 Turbo Power — JK-Products GmbH
- Ergoline Passion 40/3 Turbo Power, Soltron S-45 Flirt — JK-Products GmbH
- Ergoline/ ESSENCE 48 SMART POWER — JK-Products GmbH
- Ergoline/ ESSENCE 48 SMART POWER (PBT) — JK-Products GmbH
- Ergoline/ ESSENCE 48 SMART POWER (grey), Soltron V-50 SPACE CAB — JK-Products GmbH
- Ergoline/ Open Sun 1050, Soltron XXL-95 SHARK — JK-Products GmbH
- Ergoline/ SUNRISE 480 Turbo Power — JK-Products GmbH
- Ergoline/ SUNRISE 480 Turbo Power — JK-Products GmbH
- Ergoline/ SUNRISE 480 Turbo Power - PF — JK-Products GmbH
- Ergoline/AFFINITY 700 Advanced Performance Planet Fitness — JK-Products GmbH
- Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY — JK-Products GmbH
- Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY — JK-Products GmbH
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
- JK-Products GmbH
Sources (1)
- FDA UDI 0d003e0f-ef48-4859-8998-f0921d6c86e3 33 fields · synced May 29, 2026