Ellipse Ydun

K180406 · Ellipse A/S · GEX · Mar 15, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180406
• Device Name: Ellipse Ydun
• Applicant: Ellipse A/S
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 15, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ellipse Ydun system is intended to be used in dermatology, as tabled below: · Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Device Story

Ellipse Ydun is a laser platform console driving the Frax 1550 applicator; a 1550 nm laser diode-based handpiece. The system delivers fractionated laser light to the skin. Used in clinical dermatology settings by healthcare professionals. The console contains power units, control electronics, and a user interface. The device functions by emitting 1550 nm light to coagulate soft tissue and perform skin resurfacing. The provider operates the system via the control panel to treat the patient's skin. The device is substantially equivalent to the Ellipse Nordlys (K161162), utilizing the same Frax 1550 applicator and console design.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and performance standards compliance (bench testing).

Technological Characteristics

1550 nm laser diode-based system. Console includes power unit, control electronics, and display panel. Complies with 21 CFR 1040.10/1040.11 (Class IV Laser), IEC 60601-1, IEC 60825-1, IEC 60601-2-22, and IEC 60601-1-2. Manufactured under ISO 13485 and 21 CFR Part 820.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation and skin resurfacing.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Ellipse Nordlys with Frax 1550 (K161162)

Submission Summary (Full Text)

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March 15, 2018

Ellipse A/S Ole Kofod QA/RA Manager Agern Alle 11 Horsholm, DK-2970 DK

Re: K180406

Trade/Device Name: Ellipse Ydun Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: February 9, 2018 Received: February 14, 2018

Dear Ole Kofod:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K180406 K18xxxx (TBD)

Device Name

Ellipse Ydun

Indications for Use (Describe)

Ellipse Y dun system is intended to be used in dermatology, as tabled below: · Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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FORM FDA 3881 (8/14)

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## Special 510(k) Summary – K180406 – Section 3

# Ellipse Ydun

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.

### Submitter Information:

| Date of the summary: | 15 March 2018 |
|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by/manufacturer: | Ellipse A/S (Establishment Registration no. 3005112495)<br>Agern Alle 11<br>2970 Hoersholm, Denmark<br>Tel: + 45 4576 8808<br>Fax: + 45 4517 6851 |
| Contact person: | Ole Kofod |
| Device Identification:<br>Device Trade Name 1: | Ellipse Ydun (with Frax 1550 hand piece/applicator). |
| Device Model number 1: | 9SYS7852. |
| Common Name: | Intense Pulsed Light (IPL) & Laser. |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (per 21 CFR Part 878.4810). |
| Device classification: | Class II (per 21 CFR 870.1250). |
| Product code: | GEX |
| Predicate Devices:<br>Predicate device legally marketed<br>to which Ellipse A/S claims<br>substantial equivalence: | Ellipse Nordlys with Frax 1550 (K161162)<br>Ellipse A/S Agern Alle 11<br>DK-2970-Hørsholm, Denmark |

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### Description of Ellipse Ydun with associated Frax 1550 applicator (hand piece):

Ellipse Ydun is a platform/console capable of driving the Ellipse Frax 1550 applicator, which is a 1550 nm Laser diode-based applicator cleared by FDA under K161162.

The Ydun system consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1550 applicator connects to the system and have built in Laser diodes emitting 1550 nm light in a fractionated pattern.

### Intended Use/Indications for Use:

Ellipse Ydun system is intended to be used in dermatology, as tabled below:

- Y dun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as ● well as for skin resurfacing procedures.
### Technological Comparison

Subject device, Ellipse Ydun, is identical to the predicate device in that the Frax 1550 applicator/handpiece being used is the same as used by the predicate device and the Ellipse Ydun console driving the Frax 1550 is of the same technological design.

### Performance Standards:

The Ellipse Ydun Laser system has been tested according to and comply with:

- US FDA 21 CFR 1040.10 and 1040.11 for class IV Laser Products. ●
- IEC 60601-1 3rd edition, UL 60601-1 and CSA C22.2 No. 601.1. .
- IEC 60825-1 and IEC 60601-2-22. ●
- IEC 60601-1-2.
- Complies with the European Medical Device Directive 93/42/EEC (Annex II). ●
- Manufactured under ISO13485 Quality Management System certified by Presafe/DGM and QMI and also . complies with the US FDA 21CFR Part 820.

### Substantial Equivalence conclusion:

The Ellipse Ydun system with Ellipse Frax 1550 applicator is substantially equivalent, in terms of technological characteristics, performance, intended use/indications for use, to the predicate device (K161162) listed on page 1 of this document.

The Ellipse Ydun system has been evaluated and compared to the above mentioned predicate system and applications, parameters, and intended use/indications for use, and have been judged to be substantially equivalent to the mentioned predicate device.