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Cosmetic Treatment Package

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name
Cosmetic Treatment Package FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
COSMETIC TREATMENT PACKAGE FOR EMC FDA UDI
Model / Reference
H135A FDA UDI
Description
COSMETIC TREATMENT PACKAGE FOR EMC FDA UDI

Identifiers

Catalog Number
H135A FDA UDI
Primary DI / UDI-DI
00841494107079 FDA UDI
FDA Product Code
JOS FDA UDI
GMDN Term
Open-surgery electrosurgical electrode, monopolar, single-use 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Open-surgery electrosurgical electrode, monopolar, single-use

Cosmetic Treatment Package by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cynosure, LLC

Sources (1)

  • FDA UDI 2ff5c794-8064-46da-9b9b-a58f9710ec7b 34 fields · synced May 31, 2026