MED FLASH II INTENSE PULSED LIGHT SYSTEM.

K051508 · General Project S.R.L. · GEX · Oct 5, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051508
• Device Name: MED FLASH II INTENSE PULSED LIGHT SYSTEM.
• Applicant: General Project S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MED flash II Intense Pulsed Light System is indicated for use in: - Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction - Treatment of inflammatory acne (acne vulgaris) - Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait - Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins - The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

Device Story

MED flash II is an intense pulsed light (IPL) system for dermatological applications. Device uses a Xenon lamp to emit light radiation (590-1200 nm) via capacitor discharge. System components include a charge system, electronic control system, control panel, and a handpiece with an exchangeable lamp box and integrated cooling. Cooling system provides epidermal pre-cooling to mitigate thermal injury and patient discomfort. Operated by clinicians in a clinical setting. Output is light energy applied to the skin to treat lesions, acne, or remove hair. Clinical benefit is the reduction of unwanted hair and treatment of various dermatological conditions.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

IPL system; wavelength 590-1200 nm; Xenon lamp source; capacitor discharge power system; integrated cooling handpiece; exchangeable lamp box; electronic control system.

Indications for Use

Indicated for hair removal/reduction on all skin types, treatment of inflammatory acne, benign pigmented epidermal/cutaneous lesions (warts, scars, striae, lentigines, nevi, melasma, café-au-lait), and vascular lesions (port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial/leg veins).

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

• Palomar's StarLux V (K041086, K033549)
• Palomar's EsteLux V (K040081)
• Palomar's EsteLux G (K020941)
• Lumenis' IPL Quantum SR and the Real Time Chiller (K020839)
• Novalis Medical's Clareon Pulsed Light System (K043319)
• Cutera's Optional Pulsed Light Hand Piece Family (K050047)
• Cynosure's Photosilk and Photosilk Plus (K041095)
• General Project's Flash 1 (K022583)

Submission Summary (Full Text)

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## OCT 5 - 2005

#### 510(k) Summary of Safety and Effectiveness for the MED flash II Intense Pulsed Light System

# KOSIZOR

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

#### 1. General Information

| Submitter: | General Project S.r.l.<br>Via della Gora 15/19<br>50025 Montespertoli<br>Firenze, Italy |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | June 1, 2005 |

2. Names

| Device Name: | MED flash II Intense Pulsed Light System |
|----------------------|---------------------------------------------------------------------------------------------------|
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>Panel: Dermatology and Plastic Surgery |

#### 3. Predicate Devices

The MED flash II Intense Pulsed Light System is substantially equivalent to a combination of the following devices: Palomar's StarLux V (K041086, K033549), Palomar's EsteLux V (K040081), Palomar's EsteLux G (K020941), Lumenis' IPL Quantum SR and the Real Time Chiller (K020839), Novalis Medical's Clareon Pulsed Light System (K043319), Cutera's Optional Pulsed Light Hand Piece Family (K050047), Cynosure's Photosilk and Photosilk Plus (K041095) and General Project's Flash 1 (K022583).

#### 4. Device Description

The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intensc Pulsed Light.

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The Med flash II system contains five principal components:

- Charge system of the capacitors .
- Electronic control system .
- Control panel .
- Handpiece with exchangeable lamp box ●
- Handpiece cooling system .

#### 5. Indications for Use

The MED flash II Intense Pulsed Light System which is generally indicated for use in:

- Removal of unwanted hair from all skin types and to effect stable long-term or . permanent, hair reduction
- . Treatment of inflammatory acne (acne vulgaris)
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, . scars, striae, lentigines, nevi, melasma and café-au-lait
- . Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacca, facial and leg veins
- The integrated cooling handpiece is intended to provide pre-cooling of the . epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.
- 6. Performance Data

None presented.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 - 2005

General Project S.r.l. c/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K051508 Trade/Device Name: MED flash II Intense Pulsed Light System 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: August 25, 2005 Received: August 26, 2005

Dear Ms. ()'Connell:

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 cither 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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This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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/cdrl/dsma/dsmamain.html

ncerely vours.

Barbara Bruckner

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

Enclosure

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#### 510(k) Number (if known)

MED flash II Intense Pulsed Light System Device Name

#### Indications for Use:

The MED flash II Intense Pulsed Light System is indicated for use in:

- Removal of unwanted hair from all skin types and to effect stable long-term or . permanent, hair reduction
- Treatment of inflammatory acne (acne vulgaris) .
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, . scars, striae, lentigines, nevi, melasma and café-au-lait
- Treatment of vascular lesions, including port wine stains, hemangiomas, . angiomas, telangiectasias, rosacea, facial and leg veins
- The integrated cooling handpiece is intended to provide pre-cooling of the . epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use

(Optional Format 1-2-96)

Chulare Pradeep

Division of General, Restorative, and Neurological Devices

**510(k) Number** K051508