Identity
- Trade Name
- Ergoline Pulse PLT FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Model / Reference
- JK 191 / 40-3 PLT FDA UDI
Identifiers
- Primary DI / UDI-DI
- EJKP100004087A0 FDA UDI
- 510(k) Number
- K220500 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 Pulse PLT by JK-Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220500 also covers:
- Ergoline Pulse PLT — JK-Products GmbH
- Ergoline Spirit HLT — JK-Products GmbH
- Ergoline Spirit HLT — JK-Products GmbH
- Ergoline Spirit PLT — JK-Products GmbH
- Ergoline Spirit PLT — JK-Products GmbH
- Ergoline Vitality Hybrid Light 3 — JK-Products GmbH
- Ergoline Vitality Pure Light — JK-Products GmbH
- Ergoline Vitality Pure Light 3 — JK-Products GmbH
- Ergoline Vitality Pure Light 3 (10 min) — JK-Products GmbH
- Ergoline Vitality Total Light 3 — JK-Products GmbH
- PF PLT 42/3 RS USA — JK-Products GmbH
- PF TLT 42/3 RS USA — 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 9ef7abd3-35a3-440e-a6a8-695f11242f3e 33 fields · synced May 30, 2026