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TriFractional (TF) disposable tips
FDA UDIClass II (US FDA UDI)
by Pollogen Ltd
Identity
- Trade Name
- TriFractional (TF) disposable tips FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Device Name
- H7X7 DISPOSABLE TIP ASSY 5 PACKED FDA UDI
- Model / Reference
- H7X7 FDA UDI
- Description
- H7X7 DISPOSABLE TIP ASSY 5 PACKED FDA UDI
Identifiers
- Catalog Number
- 30010140 FDA UDI
- Primary DI / UDI-DI
- 07290016586121 FDA UDI
- 510(k) Number
- K173503 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin contouring system applicator tip
TriFractional (TF) disposable tips by Pollogen Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin contouring system applicator tip.
- INTRAgen Tip — Jeisys Medical Inc. · Class II
- Morpheus8 — Inmode MD , Ltd. · Class II
- VOLNEWMER F tip(D) — CLASSYS Inc. · Class II
- VOLNEWMER S tip — CLASSYS Inc. · Class II
- Morpheus8 Prime 12 pin TIP — Inmode MD , Ltd. · Class II
- VOLNEWMER V tip(D) — CLASSYS Inc. · Class II
- Thermage — Solta Medical, Inc. · Class I
- INTRAgen Tip — Jeisys Medical Inc. · Class II
Cleared under the same submission
K173503 also covers:
- Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Legend Pro Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Legend Pro TriFractional (TF) disposable tips — POLLOGEN LTD
- TriLift — POLLOGEN LTD
- triFX — POLLOGEN 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pollogen Ltd
Sources (1)
- FDA UDI e4947767-ed1c-43fd-a5e5-6164657d3bfa 35 fields · synced Jun 1, 2026