COSMELIGHT

K061720 · Penntack Enterprises, Inc. · GEX · Jan 31, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K061720
• Device Name: COSMELIGHT
• Applicant: Penntack Enterprises, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cosmelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow: 1. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of acne. 2. Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiormas, poikiloderma of civatte, leg veins, facial veins and venous malformations. 3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal). 4. Quick Cool Handle ( QCH ) The Quick Cool Handle is indicated for use in cooling the epidermis at the treatment Site prior to, during and after light or laser treatment in general surgery, plastic surgery And dermatology to : Reduce pain associated with light or laser treatments (via partial anesthesia from Cooling). Minimize thermal injury, including thermal necrosis, to non target skin and skin Structures during light or laser treatments, thus reducing the possibilities of scabbing, scarring, hypo and / or hyper pigmentation. Allows the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatme of vascular or pigmented lesions.

Device Story

Cosmelight Intense Pulsed Light (IPL) system; delivers light energy via removable handpieces; wavelengths 400-950nm (acne), 560-1200nm (pigmented/vascular lesions), 700-1200nm (hair removal). Includes Quick Cool Handle (QCH) for epidermal cooling; reduces pain/thermal injury; allows higher fluences. System comprises control console, display panel, power supply, handpieces with integrated trigger switch. Used in clinical settings by healthcare professionals. Output: pulsed light energy for photothermolysis/photocoagulation. Clinical benefit: treatment of dermatological conditions and hair removal with reduced risk of thermal necrosis/pigmentation changes.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

IPL system; wavelengths 400-1200nm; includes control console, power supply, and handpieces with integrated cooling (QCH). Energy source: Intense Pulsed Light. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for patients requiring dermatological treatment for inflammatory acne, benign pigmented lesions (epidermal/cutaneous), benign vascular lesions (e.g., port wine stains, hemangiomas, telangiectasias, rosacea, melasma, angiomas, venous malformations), and unwanted hair removal. Includes use of Quick Cool Handle for epidermal cooling to reduce pain and thermal injury during light/laser procedures.

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

• Lumenis Inc IPL Quantum (K020839)
• Palomar Inc. EsteLux (K020453)
• McCue Plc. McCue Energist ULTRA (K040659)
• DDD A/S, Ellipse I2 PL (K060516)

Submission Summary (Full Text)

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## 6 1720

## Section 3 - 510(k) Summary Re: 061720

JAN 3 1 2007

This 510(k) summary of safety and effectiveness for the Cosmelight Intense Pulsed Light system by Penntack Enterprises Inc. is submitted in accordance with the requirements of the Safe Medical Devise Act (SMDA) of 1990 and follows the office of Devise Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

| Applicant : | Penntack Enterprises Inc. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address : | 3321 NW 79 ST. Miami, FL 33147 |
| Contact Person : | Paul Pena ( Director ) |
| Telephone : | 305-835-0411 |
| Preparation Date : | May 5, 2006 |
| Device Trade Name: | Cosmelight |
| Common Name : | Intense Pulsed Light System |
| Classification Name | Laser surgical instrument for use in general and plastic and<br>dermatology.<br>21 CFR 878.4810<br>Product Code: GEX<br>Panel: 79 |
| Legally-marketed | The Cosmelight is substantially equivalent to the following currently |
| Predicate Devices: | marketed devices: |
| | Lumenis Inc IPL Quantum, K020839 |
| | Palomar Inc. EsteLux, K020453 |
| | McCue Plc. McCue Energist ULTRA, K040659 |
| | DDD A/S , Ellipse I2 PL, K060516 |
| System Description: | The Cosmelight Intense Pulsed Light System is comprised of the<br>following main components: |
| | • A control console unit. |
| | • A control and color display panel. |
| | • Two removable handpieces with an integrated trigger switch<br>and a Cooling System (a cooling device integrated into the<br>handpieces. Quick Cool Handle ( QCH ) |
| | • Power supply. |
| Indicated Use : | The Cosmelight Intense Pulsed Light System (and its accessories)<br>are indicated for use in surgical, aesthetic and cosmetic<br>applications (requiring photothermolysis, photocoagulation and<br>dermatology) in the treatment of acne, various benign pigmented<br>lesions and hair removal as follow: |
| | 1. Intense Pulse Light Energy Wavelengths from 400 - 950 nm<br>are indicated for the treatment of acne. |
| | 2. Intense Pulse Light Energy Wavelengths from 560 - 120 0 nm<br>are indicated for the treatment of benign pigmented (epidermal |
| | and coetaneous) lesions including warts, scars and striae. For the<br>treatment of benign (cutaneous) vascular lesions including port<br>wine stains, hemangiomas, facial, truncal and leg telangiectasias,<br>rosacea, melasma, angiomas and spider angiormas, poikiloderma<br>of civatte, leg veins, facial veins and venous malformations. |
| | 3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm<br>are indicated for the treatment of unwanted hair (i.e., hair<br>removal). |
| | 4. Quick Cool Handle ( QCH ) |
| | The Quick Cool Handle is indicated for use in cooling the<br>epidermis at the treatment Site prior to, during and after<br>light or laser treatment in general surgery, plastic surgery<br>And dermatology to :<br>Reduce pain associated with light or laser treatments<br>(via partial anesthesia from Cooling). |
| | Minimize thermal injury, including thermal necrosis, to<br>non target skin and skin Structures during light or laser<br>treatments, thus reducing the possibilities of scabbing,<br>scarring, hypo and / or hyper pigmentation. |
| | Allows the use of higher light or laser fluences for light<br>or laser treatments (such as for hair removal and the treatme<br>of vascular or pigmented lesions. |
| Performance Data : | The differences in specifications of the Cosmelight system and the<br>Predicate devices do not result in different performance or raise<br>new questions of safety and efficacy. |
| Conclusion : | Based on the foregoing, the Cosmelight system is substantially<br>Equivalent to the legally-marketed predicate devices mentioned<br>above. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Penntack Enterprises, Inc. % Mr. Paul Pena Director 3321 NW 79th Street Miami, Florida 33147

JAN 3 1 2007

Re: K061720

Trade/Device Name: Cosmelight 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: November 24, 2006 Received: November 28, 2006

Dear Mr. Pena:

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. Paul Pena

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 [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,

Mark N. Melkerson

son 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

510(K) Number (if known): K061720

Device Name: Cosmelight

Indications for Use:

The Cosmelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, varlous benign pigmente lestons and hair removal as follow:

Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the reatment of: inflammatory acne.

2. Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of: benign pigmented (epidermal and coetaneous) lesions including warts, cars and striae. For the treatment of benign (cutaneous) vascular lessons including ort wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.

3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of: unwanted hair (i.e., hair removal).

Prescription Use Part 21 CFR 801 Subpart D ) OR

Over-The-Counter Use ( 21CFR 807 Subpart C )

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510(k) Number

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