ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM

K082825 · Energist, Ltd. · GEX · Feb 6, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082825
• Device Name: ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
• Applicant: Energist, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions. Intense Pulsed Light Energy / wavelengths (530 950nm) . The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations. Intense Pulsed Light Energy / wavelengths (610 - 950nm) The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles. * Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen. Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.

Device Story

Energist ULTRAPLUS VPL is an intense pulsed light (IPL) system for dermatological applications. Device delivers filtered light energy at specific wavelengths (415/630-950nm, 530-950nm, 610-950nm) to target chromophores in skin, including melanin in hair follicles, hemoglobin in vascular lesions, and inflammatory acne components. Operates via selective photothermolysis and photocoagulation principles. Used in clinical settings by trained professionals. Output is controlled light pulses applied to skin surface. Clinical benefit includes reduction of unwanted hair, clearance of vascular/pigmented lesions, and management of inflammatory acne. Provider monitors treatment response visually to adjust energy parameters.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Intense Pulsed Light (IPL) system; utilizes variable pulsed light (VPL) technology. Wavelength ranges: 415/630-950nm, 530-950nm, and 610-950nm. Energy delivery via handpiece applicator. Standalone clinical device. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for permanent hair reduction (skin types I-V) and treatment of mild to moderate inflammatory Acne Vulgaris. Also indicated for photocoagulation/photothermolysis of benign pigmented lesions (warts, scars, striae) and benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, melasma, angiomas, Poikiloderma of Civatte, leg veins, venous malformations).

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

## Public Health Service

FEB - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Energist. Ltd. % Mr. Tim Major Engineering Director Clos Llyn Cwm, Valley Way Enterprise Park, Swansea, SA6 8QY United Kingdom

Re: K082825

Trade/Device Name: Energist ULTRAPLUSTM VPL 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: December 4, 2008 Received: December 8, 2008

Dear Mr. Major:

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

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Page 2 - Mr. Tim Major

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 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 the reporting 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 yours.

Mark N. Mullerson

Mark N. Melkerson 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): K 082825

Energist ULTRAPLUS™ VPL Intense Pulsed Light System Device Name:

Indications for Use:

The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

- Intense Pulsed Light Energy / wavelengths (530 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.

Intense Pulsed Light Energy / wavelengths (610 - 950nm)

The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

* Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.

| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|------------------|---------------------------------------------|
| | AND/OR |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Concurrence of CDRH | (Division Sign-Off) (ODE) |
|---------------------|---------------------------|
|---------------------|---------------------------|

Division of General, Restorative, and Neurological Devices

| 510(k) Number | |
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|---------------|--|

| Section 4 | Confidential | Page 2 |
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