ELLIPSE LIGHT SPT

K043255 · Danish Dermatologic Development A/S · GEX · Feb 24, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043255
• Device Name: ELLIPSE LIGHT SPT
• Applicant: Danish Dermatologic Development A/S
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ellipse I2PL is intended for use in dermatology. - Hair removal (permanent hair reduction). - Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness).

Device Story

Ellipse I2PL is an Intense Pulsed Light (IPL) system for dermatologic use; operated by clinicians in a clinic setting. Device consists of a console with power unit, control electronics, and software-driven display panel. Applicators/hand-pieces generate broad-spectrum light (555-950 nm) to target hair follicles or pigmented/vascular lesions. System utilizes circulating water for hand-piece cooling. Clinician selects treatment parameters via touch screen; light energy is delivered to the skin surface. Output affects clinical decision-making by enabling non-invasive removal of unwanted hair and treatment of benign skin lesions. Benefits include permanent hair reduction and improvement of skin appearance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison, intended use, and performance characteristics relative to legally marketed predicate devices.

Technological Characteristics

Intense Pulsed Light (IPL) system; broad-spectrum light (555-950 nm). Energy output 0-21 J/cm²; pulse duration 5-55 mS. Features touch screen interface, software-controlled parameters, and circulating water cooling for hand-pieces. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for permanent hair reduction and treatment of benign pigmented and vascular lesions in patients with Fitzpatrick Skin Types 1-6 (depending on applicator) and 1-4 (for pigmented/vascular lesions). Contraindicated for certain skin types/conditions as specified in the treatment matrix; caution advised for darker skin types (4+) or suntanned skin.

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

• IPL™ Quantum (K024093; K020839)
• Skin Station™ (K030897)
• EsteLux™ (K020453)

Reference Devices

• EsteLux™ (K991935, K984110)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K043255

## Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL system.

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: | 11 February 2005 |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by/manufacturer: | Danish Dermatologic Development A/S<br>Agern Alle 11<br>2970 Hoersholm, Denmark<br>Tel: + 45 4576 8808<br>Fax: + 4517 6851 |
| Contact person: | Ole Kofod |
| Device Trade Name: | Ellipse I2PL. |
| Device Model number: | 9ESL7228. |
| Common Name: | Intense Pulsed Light (IPL) system. |
| 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 DDD<br>claims equivalence: | IPL™ Quantum (K024093; K020839) 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>Skin Station™ (K030897) manufactured by Radiancy Inc., 40<br>Ramland Road South, Suite 10, Orangeburg, New York 10962,USA.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)).<br>EsteLux™ (K020453) manufactured by Palomar Medical<br>Technologies, Inc., 82 Cambridge Street, Burlington, MA 01803.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)). |

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<043255

#### B. Description of Ellipse I2PL:

Ellipse If PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores and diffuse redness in the area of dermatology.

The system consists of a console containing power unit and control electronics with control and display panel including software.

Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 555 nm - 950 nm.

#### C. Intended Use of Ellipse I-PL:

Ellipse I2PL is intended for use in dermatology.

- Hair removal (permanent hair reduction). .
- Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, . mottled pigmentation) and benign vascular lesions (diffuse redness). The Indications for Use for Ellipse I'PL 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 | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care and attention. | | | | | | | |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |

#### D. Comparison of Ellipse I2PL to predicate devices:

| | Ellipse I²PL | IPL™ Quantum | Skin Station™ | EsteLux™ |
|----------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) reference | Current submission | K024093; K020839 | K030897 | K020453 |
| Technology/<br>Operation/<br>Device<br>description | Intense Pulsed Light<br>(IPL)/broad spectrum<br>light/touch screen<br>operation. | Intense Pulsed Light<br>(IPL)/broad spectrum<br>light/touch screen<br>operation. | Intense Pulsed Light<br>(IPL)/broad<br>spectrum. Knob<br>operation. | Intense Pulsed Light<br>(IPL)/broad<br>spectrum. Knob<br>operation with<br>display. |
| Intended Use | Hair removal and<br>the treatment of<br>benign pigmented<br>and vascular lesions | Hair removal,<br>treatment of tattoos,<br>benign pigmented<br>and benign vascular<br>lesions | Hair removal and<br>treatment of<br>pigmented and<br>vascular lesions | Hair reduction,<br>treatment of facial<br>and leg veins and<br>vascular and benign<br>pigmented lesions |
| Energy spectrum | 555-950 nm | 515-1200 nm * | 400-1200 nm | 470-1400 nm |
| Energy ouput/<br>setting | 0-21 J/cm² | 15-45 J/cm² * | 3-10 J/cm² | 12-40 J/cm² |
| Pulse duration | 5-55 mS | 2-16 mS<br>(to 48 mS triple<br>pulsed). * | 10 and 35 mS | 10-100 mS |

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# 人043255

| | Ellipse I²PL | IPL™ Quantum | Skin Station™ | EsteLux™ |
|-------------------------------------|--------------------------------------------|------------------------------------------------------------|------------------------------|------------------------------------------------------|
| 510(k) reference | Current submission | K024093; K020839 | K030897 | K020453 |
| Applicator/hand-<br>piece spot size | 10 x 48 mm | 8 x 34 mm | 22 x 55 mm and<br>35 x 12 mm | 16 x 46 mm, 12 x 28<br>mm, 12 x 12 mm, 10<br>x 15 mm |
| Charge time/<br>repetion rate | 1.5-2.0 Sec. | 2 Sec. | N/A | 1 Sec. |
| Cooling method | Cooling handpiece by<br>circulating water. | Skin cooling<br>components<br>integrated in hand<br>piece. | N/A | Skin cooling possible<br>with Cool Roller™ |
| Device<br>classification | II; 21 CFR 878.4810,<br>GEX | II; 21 CFR 878.4810,<br>GEX | II; 21 CFR 878.4810,<br>GEX | II; 21 CFR 878.4810,<br>GEX |

* See conclusion.

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## 15 04 725

#### Conclusion:

IPI."M Quantum has a broader range of applications than Ellipse I PL. IPLTM Quantum may be updated with a Laser module for vascular treatment applications in addition to the IPL modules. Ellipse IPL does not employ a Laser module, only IPL, Ellipse I PL thus utilizes a

subset of the IPL TM Quantum applications.

SkinStation™ has identical range of applications as Ellipse I'PL, and the intended use and the performance is substantially equivalent.

EsteLux " has a broader range of applications than Ellipse I-PL, the intended use for Eilipse I2PL is covered by the EsteLux "M and the performance is substantially equivalent.

The systems and identical application modules utilized by IPL™ Quantum (Lumenis, Inc.), Skin Station™ (Radiancy Ltd.) , and EsteLux™ (Palomar) have been evaluated and compared to Ellipse I2PL. The Ellipse I-PL system, as far as these identical modules, applications and intended uses are concerned, are judged to be substantially equivalent to the IPL™ Quantum (predicate device cleared in K024093, K020839), SkinStation™ (predicate device cleared in K030897), and EsteLux™ (predicate device cleared in K991935, K984110).

Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S believes that no significant differences exist. The Ellipse I-PL system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its wing.

Public Health Service

FEB 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ole Kofod OA/RA Manager, Operations Manager Danish Dermatologic Development A/S Agern Alle 11 DK-2970 Hoersholm Denmark

Re: K043255 Trade/Device Name: Ellipse I- PL. 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: November 19, 2004 Received: November 26, 2004

Dear Mr. 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.

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Page 2 - Mr. 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), pleasc contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Stupt Rhodes
Celia M. Witten, Ph.D., M.D.

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

Enclosure

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#### Indications for Use

K043255 510(k) Number:

Ellipse I2PL Device Name:

Indications for Use:

The Intended Use for Ellipse I2PL is:

Ellipse 12PL. is intended for use in dermatology.

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

The Indications for Use for Ellipse I2PL 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 | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care and<br>attention. | | | | | | | |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |

Prescription Use

AND/OR

(Part 21 C.F.R. 801 Subpart D)

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

WDC- 23663/0001 - 2063040 v3
510(k) Number K043255