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Morpheus8

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name
Morpheus8 FDA UDI
Generic Name
Radio-frequency skin contouring system applicator tip FDA UDI
Device Name
Morpheus8 3D 40p Tip FDA UDI
Model / Reference
AG609135A_3D FDA UDI
Description
Morpheus8 3D 40p Tip FDA UDI

Identifiers

Catalog Number
AG609135A_3D FDA UDI
Primary DI / UDI-DI
17290016633624 FDA UDI
510(k) Number
K192695 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin contouring system applicator tip

Morpheus8 by Inmode MD , 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.

Cleared under the same submission

K192695 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inmode MD , Ltd.

Sources (1)

  • FDA UDI 3884f255-833d-4cef-a51a-ef2baf9efe5c 37 fields · synced Jun 8, 2026