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TempSure System, Surgical

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 100-7027-510

by Cynosure LLC

Identity

Trade Name
TempSure System, Surgical EUDAMED
ASSY, Final TempSure System, Surgical FDA UDI
Generic Name
Electrosurgical system FDA UDI
Device Name
TempSure System, Surgical EUDAMED
ASSY, Final TempSure System, Surgical FDA UDI
Model / Reference
100-7027-510 EUDAMEDFDA UDI
Description
ASSY, Final TempSure System, Surgical FDA UDI

Identifiers

Primary DI / UDI-DI
00841494108069 EUDAMEDFDA UDI
Basic UDI-DI
B-00841494108069 EUDAMED
510(k) Number
K182365 FDA UDI
FDA Product Code
GEX FDA UDI
EMDN Code
K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term
Electrosurgical system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microwave ablation system probe, non-powered

The TempSure Surgical RF System (Nomenclature Code: K02030199) is a reusable, Class IIb radiofrequency (RF) surgical device designed for tissue coagulation and incision. It operates at a frequency of 4 MHz, delivering controlled energy to achieve precise surgical outcomes with reduced lateral thermal damage to adjacent tissues.

This system is intended for use in surgical settings and is supplied as a reusable device, requiring reprocessing between uses. It is not sterile out-of-box and must be sterilized prior to use. The device carries FDA 510(k) and MDD authorizations, adhering to regulatory standards for Class IIb medical devices. The UDI (Basic UDI: B-00841494108069) ensures traceability and compliance with global regulatory requirements.

Similar devices

Also classified as Microwave ablation system probe, non-powered.

Frequently asked questions

Is the TempSure Surgical RF System intended for single-use or can it be reused after reprocessing?

The TempSure Surgical RF System is designed as a reusable device, meaning it must be properly reprocessed between uses. It is not sterile out-of-the-box and requires sterilization prior to each surgical application, as indicated by the 'STERILE: 0' and 'REPROCESSED: 0' fields in the specifications.

What frequency does the TempSure Surgical RF System operate at, and what is its primary surgical purpose?

The TempSure Surgical RF System operates at 4 MHz and is designed specifically for tissue coagulation and incision in surgical settings. Its controlled energy delivery helps achieve precise outcomes while minimizing lateral thermal damage to surrounding tissues.

How is the device identified for regulatory and traceability purposes, and who is the manufacturer?

The device is identified by its Basic UDI (B-00841494108069) for traceability and compliance. The manufacturer is Cynosure LLC (US-MF-000010200), while the authorized representative in the EU is Cynosure B.V. (NL-AR-000009566). The system holds FDA 510(k) and MDD authorizations, confirming its regulatory status.

Does the TempSure Surgical RF System come in multiple models or sizes, and if so, what are the available options?

The provided data lists a single device model (100-7027-510) for the TempSure Surgical RF System. No additional models or sizes are specified in the documentation, so this appears to be the sole configuration available for purchase.

What storage or handling precautions should be taken for the TempSure Surgical RF System before sterilization?

Since the system is not sterile out-of-the-box (STERILE: 0), it must be sterilized prior to use. While specific storage instructions aren’t detailed, standard precautions for reusable surgical devices—such as protecting from contamination, moisture, or physical damage—should be followed. Always adhere to the manufacturer’s reprocessing guidelines to ensure safety and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TempSure® Surgical RF Technology - Cynosure Lutronic, TempSure® Platform - Cynosure Lutronic, Monopolar Radiofrequency Platform - Tempsure® Platform - Cynosure

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Cynosure LLC
EUDAMED SRN
US-MF-000010200
Authorised Representative
Cynosure B.V. NL-AR-000009566

Sources (3)

  • EUDAMED 2c274a5f-ee80-49c0-ab70-b10188e92d6c 61 fields · synced Sep 18, 2026
  • FDA UDI 4c9070ac-6c25-4437-a975-8888763b1236 34 fields · synced May 30, 2026
  • FDA 510(k) K212891 1 fields · synced May 18, 2026