ELLIPSE MULTIFLEX

K081408 · Ellipse A/S · GEX · Oct 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081408
• Device Name: ELLIPSE MULTIFLEX
• Applicant: Ellipse A/S
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ellipse MultiFlex is intended for use in dermatology. Ellipse MultiFlex used with IPL applicators (9APP7133, 7116, 7114, 7134, 7212, 7377, 7213): - . Hair removal (permanent hair reduction). - . Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains). - Treatment of inflammatory acne. . Ellipse MultiFlex used with Nd: YAG applicator (9APP7472): - Treatment of leg vessels (0.1 3.0 mm diameter). .

Device Story

Ellipse MultiFlex is a dermatological system consisting of a console with power unit, control electronics, and display panel. It delivers light energy via interchangeable handpieces: Intense Pulsed Light (IPL) applicators (400-950 nm) or a 1064 nm Nd:YAG laser applicator. The system is operated by healthcare professionals in a clinical setting. The provider selects treatment parameters via the control panel; the device generates light pulses to target specific chromophores in the skin. IPL is used for hair removal, pigmented/vascular lesions, and acne; the Nd:YAG handpiece is used for leg vessels (0.1-3.0 mm). Output affects clinical decision-making by enabling non-invasive treatment of dermatological conditions, potentially providing patients with cosmetic improvement and lesion reduction.

Clinical Evidence

Bench testing only. The device complies with US FDA 21 CFR 1040.10/1040.11, IEC 60601-1, UL 60601-1, CSA C22.2 No. 601.1, IEC 60825-1, IEC 60601-2-22, and IEC 60601-1-2. No clinical data provided.

Technological Characteristics

System consists of a console with power unit and control electronics. IPL applicators (400-950 nm) and Nd:YAG laser applicator (1064 nm). Complies with IEC 60601-1, IEC 60825-1, and IEC 60601-2-22. Manufactured under ISO 13485. Software-controlled interface.

Indications for Use

Indicated for dermatology patients requiring permanent hair reduction, treatment of benign pigmented lesions (solar lentigines, ephilides, mottled pigmentation), benign vascular lesions (diffuse redness, telangiectasias, port wine stains), inflammatory acne, and leg vessels (0.1-3.0 mm diameter). Applicable to Fitzpatrick skin types I-V (some applications up to VI). Contraindicated for certain skin types per treatment matrix.

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

• Multi-Spot Nd:YAG (K060448)
• Alma Harmony long pulsed Nd:YAG (K033946)
• Lux1064 (K041879)
• Ellipse Flex PPT (K052688)

Submission Summary (Full Text)

{0}------------------------------------------------

# Ellipse A/S

K081408

## Ellipse MultiFlex with Nd:YAG handpiece

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

#### A. Contact information and device identification:

| Date of the summary: | 16 May 2008<br>OCT 17 2008 |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by/manufacturer: | Ellipse A/S<br>Agern Alle 11<br>2970 Hoersholm, Denmark<br>Tel: + 45 4576 8808<br>Fax: + 45 4517 6851 |
| Contact person: | Ole Kofod |
| Device Trade Name: | Ellipse MultiFlex (with IPL and Nd:YAG handpieces). |
| Device Model number: | 9ESF7496 system (with 9APP7472 Laser handpiece). |
| 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. |
| Product code: | GEX |
| Predicate devices legally<br>marketed to which Ellipse<br>A/S claims substantial<br>equivalence: | Multi-Spot Nd:YAG (K060448) manufactured by<br>Lumenis Inc., 2400 Condensa Street, Santa Clara, CA 95051, USA.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)).<br><br>Alma Harmony long pulsed Nd:YAG (K033946) manufactured by<br>MSq(M2) Ltd., 7 Haeshel St., P.O.B. 3021, Caesarea Industrial park,<br>38900 Israel.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)).<br><br>Lux1064 (K041879) manufactured by<br>Palomar Medical Technologies, Inc., 82 Cambridge Street,<br>Burlington, MA 01803, USA.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)).<br><br>Ellipse Flex PPT (K052688) manufactured by<br>Ellipse A/S, Agern Alle 11, DK-2970 Hoersholm, Denmark, as far as<br>all IPL applications concerns.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)). |

{1}------------------------------------------------

### B. Description of Ellipse Multiflex:

Ellipse Multiflex is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains and inflammatory acne in the area of dermatology, The system consists of a console containing power unit and control electronics with control and display panel including software.

IPL Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 400 nm - 950 nm.

The above was cleared under K052688.

Additionally a Nd:YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex for treatment of vascular lesions as stated under Intended Use.

### C. Intended Use:

Ellipse MultiFlex is intended for use in dermatology.

Ellipse MultiFlex used with IPL applicators (9APP7133, 7116, 7114, 7134, 7212, 7377, 7213):

- . Hair removal (permanent hair reduction).
- . Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne. .

Ellipse MultiFlex used with Nd: YAG applicator (9APP7472):

- Treatment of leg vessels (0.1 3.0 mm diameter). .
### D. Performance Standards

The Ellipse MultiFlex Intense Pulsed Light (IPL) and Laser system has been tested according to and complies with:

- · US FDA 21 CFR 1040.10 and 1040.11 for class IV Laser Products.
- IEC 60601-1, 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 DGM and QM1. .

#### E. Substantial Equivalence conclusion:

The Ellipse MultiFlex system is substantially equivalent in terms of technological characteristics, performance, intended use/indications for use to the predicate devices listed on page 1 of this document. All the stated intended uses of Ellipse MultiFlex with Nd:YAG has earlier been investigated and cleared by FDA for equipment which the performed comparison has shown to be substantially equivalent to regarding the applications in question.

The IPL Intended Use applications, as already cleared under K052688 for Ellipse Flex PPT, is maintained for the Ellipse MultiFlex used with IPL handpieces/applicators. The system platform remains. Ellipse MultiFlex is the next generation of the Ellipse Flex PPT which incorporates a Nd: YAG handpiece in addition to the IPL handpieces.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a series of curved lines, and the text is in a simple, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ellipse A/S % Ole Kofod Agern Allé 11 DK-2970 Hørsholm Denmark

OCT 1 7 2008

Re: K081408 Trade/Device Name: Ellipse MultiFlex Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 2, 2008 Received: September 3, 2008

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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ole Kofod

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### 510(k) Notification

#### Device Name:

### Ellipse MultiFlex

K081408

#### Indications for Use:

Ellipse MultiFlex is intended for use in dermatology.

Ellipse MultiFlex used with IPL applicators (9APP7133, 7116, 7114, 7134, 7212, 7377, 7213):

- Hair removal (permanent hair reduction). .
- Treatment of benign pigmented lesions (including, but not limited to solar lentigines, � ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
- . Treatment of inflammatory acne.

Ellipse MultiFlex used with Nd: YAG applicator (9APP7472):

- Treatment of leg vessels (0.1 3.0 mm diameter). t
#### The Indications for Use for Ellipse MultiFlex are:

| Application | Treatment Variable | Fitzpatrick Skin Type | | | | | |
|----------------------------------------------------------------------|-----------------------------------|-----------------------|---|---|---|---|---|
| | | 1 | 2 | 3 | 4 | 5 | 6 |
| Hair Removal<br>HR Applicator<br>HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal<br>HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions<br>and Benign Vascular Lesions | Pigmentation / Vessel Size | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Telangiectasias | Vessel size (Thin, medium, thick) | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Port Wine Stains | Color (Red, blue) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Individual Pigmented Lesions | Pigment Color | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Inflammatory Acne | | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K081408

(Signature)

Ole Kofod
(Typed Name)

(Date)

(Premarket Notification 510(k) Number)

Prescription Use X
AND/OR
Over-The-Counter Use

(21CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(21 CFR 801 Subpart C)