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Hybrid Energy (HE) disposable tips

FDA UDI

Class II (US FDA UDI)

by Pollogen Ltd

Identity

Trade Name
Hybrid Energy (HE) disposable tips FDA UDI
Generic Name
Radio-frequency skin contouring system applicator tip FDA UDI
Model / Reference
gen12 FDA UDI

Identifiers

Catalog Number
30010080 FDA UDI
Primary DI / UDI-DI
07290016586060 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

No

FDA UDI

Category: Radio-frequency skin contouring system applicator tip

Hybrid Energy (HE) 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pollogen Ltd

Sources (1)

  • FDA UDI a5c6e5d1-dad6-4a97-ab84-e79ac152a85c 33 fields · synced May 30, 2026