ELLIPSE 12PL, MODEL 9ESL7228
Device Facts
| Record ID | K060516 |
|---|---|
| Device Name | ELLIPSE 12PL, MODEL 9ESL7228 |
| Applicant | Danish Dermatologic Development A/S |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 15, 2006 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for 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 (including but not limited to diffuse redness, telangiectasias, port wine stains). - Treatment of inflammatory acne.
Device Story
Ellipse I2PL is an Intense Pulsed Light (IPL) system for dermatological applications. Device consists of a console with power unit, control electronics, and touch-screen interface; connected to interchangeable applicators/hand-pieces. System generates broad-spectrum light (400-950 nm) to target hair follicles, pigmented lesions, vascular structures, or acne. Hand-pieces feature integrated water-cooling. Operated by clinicians in dermatological settings. Physician selects treatment parameters based on patient Fitzpatrick skin type and lesion characteristics; light energy delivered via hand-piece to skin surface. Output affects tissue through photothermolysis; clinical benefit includes hair reduction and lesion clearance. No clinical data provided; substantial equivalence based on comparison to predicate devices.
Clinical Evidence
Bench testing only. No clinical data presented.
Technological Characteristics
Intense Pulsed Light (IPL) system; broad spectrum 400-950 nm; energy output 0-26 J/cm²; pulse duration 1.5-100 ms; spot size 10 x 48 mm. Cooling via circulating water in hand-piece. Touch-screen control interface. Class II device (21 CFR 878.4810).
Indications for Use
Indicated for permanent hair reduction, treatment of benign pigmented lesions (solar lentigines, ephilides, mottled pigmentation), benign vascular lesions (diffuse redness, telangiectasias, port wine stains), and inflammatory acne. Applicable to Fitzpatrick skin types 1-4 for most treatments; skin types 1-5 for specific hair removal applicators; skin type 6 only for HR-D hair removal applicator.
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
Submission Summary (Full Text)
{0}------------------------------------------------
K 060516
# 510(k) SUMMARY
MAY 15220066
## 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: | 1 February 2006 |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by/manufacturer: | Danish Dermatologic Development 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 I2PL. |
| Device Model number: | 9ESL7228-B02. |
| 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: | Ellipse I2PL (K043255) manufactured by Danish Dermatologic<br>Development A/S, Agern Alle 11, DK-2970 Hoersholm, Denmark.<br>(Laser surgical instrument for use in general and plastic surgery and<br>in dermatology (per 21 CFR Part 878.4810)).<br>Ellipse Flex PPT (K052688) manufactured by Danish Dermatologic<br>Development A/S, Agern Alle 11, DK-2970 Hoersholm, Denmark.<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 I2PL:
Ellipse I2PL 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, 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.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 400 nm - 950 nm.
### C. Intended Use of Ellipse I2PL:
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 (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne. .
| 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 | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| 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 | | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |
The Indications for Use for Ellipse if PL are:
{2}------------------------------------------------
| | Ellipse I²PL (B02) | Ellipse Flex PPT | Ellipse I²PL (A01) |
|-------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| 510(k) reference | This submission | K052688 | K043255 |
| Technology/ | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light |
| Operation/ | (IPL)/broad spectrum | (IPL)/broad spectrum | (IPL)/broad spectrum |
| Device | light/touch screen | light/touch screen | light/touch screen |
| description | operation. | operation. | operation. |
| Intended Use | Hair removal and the<br>treatment of benign<br>pigmented and | Hair removal and the<br>treatment of benign<br>pigmented and | Hair removal and the<br>treatment of benign<br>pigmented and |
| | vascular lesions; | vascular lesions; | vascular lesions; |
| | Treatment of | Treatment of | Treatment of |
| | Inflammatory Acne. | Inflammatory Acne. | Inflammatory Acne. |
| Energy spectrum | 400-950 nm | 400-950 nm | 555-950 nm |
| Energy ouput/<br>setting | 0-26 J/cm² | 0-26 J/cm² | 0-26 J/cm² |
| Pulse duration | 1,5-100 ms | 1,5-100 ms | 5-55 ms |
| Applicator/hand-<br>piece spot size | 10 x 48 mm | 10 x 48 mm | 10 x 48 mm |
| Charge time/<br>repetion rate | 1.5-2.0 s | 1.5-2.0 s | 1.5-2.0 s |
| Cooling method | Cooling handpiece by<br>circulating water. | Cooling handpiece by<br>circulating water. | Cooling handpiece by<br>circulating water. |
| Device | II; 21 CFR 878.4810, | II; 21 CFR 878.4810, | II; 21 CFR 878.4810, |
| classification | GEX | GEX | GEX |
### D. Comparison of Ellipse It PL to predicate devices:
#### Conclusion:
The Ellipse I2PL (B02) has been evaluated and compared to its predicate systems (to Ellipse If PL (A01) (manufactured by DDD), and Ellipse Flex PPT (manufactured by DDD)). The Ellipse I2PL (B02) system, as far as the identical modules, applications and intended uses are concerned, are identical to Ellipse IPL (A01) and identical and substantially equivalent to the Ellipse Flex PPT with regards to technology as well as modules, applications and intended uses.
Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S (DDD) concludes that no significant differences exist. The applications added to the original Ellipse IPL system does not raise new issues of safety and effectiveness and is substantially equivalent to the monthoned predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of four stylized human figures connected at the shoulders, with their arms raised. The figures are depicted in a simple, abstract manner, and the overall design is clean and professional.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 15 2006
Danish Dermatologic Development A/S c/o Mr. Ole Kofod QA/RA Manager Agern Alle 11 2970 Hoersholm, Denmark
Re: K060516
Trade/Device Name: Ellipse I2PL 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: February 1, 2006 Received: February 27, 2006
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
{4}------------------------------------------------
#### Page 2 - Mr. Ole Kofod
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. 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 Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
# Indications for Use
| 510(k) number: | K060516 |
|----------------|---------|
|----------------|---------|
Ellipse I2PL Device Name:
Indications for Use:
The Intended Use for Ellipse I²PL is:
Ellipse IPPL 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 (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne. .
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 / 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 | | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |
Prescription Use X (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
.gmall
(Division Sign-O Division of General, Restorative. and Neurological Devices
510(k) Number_ko60516
