ACCELA SYSTEM

K081578 · Genesis Biosystems, Inc. · GEX · Jun 20, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081578
• Device Name: ACCELA SYSTEM
• Applicant: Genesis Biosystems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Indications for Use for Fitzpatrick skin types (I to VI) - The removal of unwanted hair and to effect stable long-term or *permanent hair . reduction. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. - The treatment of moderate inflammatory acne vulgaris t - The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles) - . The treatment of cutaneous lesions including warts, scars, and striae. . The treatment of benign cutaneous vascular lesions, including port wine stains, 4 hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during and/or with light or laser treatment (via partial anesthesia from . cooling) - Reduce discomfort during and/or associated with light or laser treatment . - Minimize thermal injury, including thermal necrosis, to non-target skin and skin . structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation - Allow the use of higher light or laser fluences for light or laser treatments (such as for . hair removal and the treatment of vascular or pigmented lesions) - Reduce potential side effects of light or laser treatments (such as for hair removal . and the treatment of vascular or pigmented lesions)

Device Story

Accela System is an Intense Pulsed Light (IPL) device using a xenon flash lamp to deliver light (400nm-1200nm) to the dermis for aesthetic therapies. Device features a 50mm x 50mm treatment area and integrated convective cold air cooling in the handpiece to protect the epidermis. Operated by clinicians in a clinic setting; light energy is applied to the skin surface to target hair follicles, vascular lesions, or pigmented structures. Integrated cooling provides partial anesthesia and thermal protection, allowing for higher fluence usage. Output is controlled by the operator via programmable pulse characteristics. Clinical benefit includes hair reduction, lesion clearance, and reduced thermal injury/discomfort during treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance similarities to predicate devices.

Technological Characteristics

Intense Pulsed Light (IPL) device using xenon flash lamp technology. Spectral output: 400nm-1200nm. Treatment area: 50mm x 50mm. Repetition rate: <= 0.5Hz. Integrated convective cold air cooling system. Complies with UL60601-1:1996 and European Medical Directive 93/42/EEC.

Indications for Use

Indicated for Fitzpatrick skin types I-VI for hair removal, treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides), cutaneous lesions (warts, scars, striae), and benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins). Integrated cooling indicated for epidermal cooling during aesthetic dermatologic/plastic surgery procedures to reduce pain/discomfort, minimize thermal injury, and allow higher fluences.

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

• Chromogenex (K053324)
• Sciton (K032460)
• Lumenis (K020839)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for Genesis Biosystems. The word "Genesis" is on the top line, and the word "Biosystems" is on the bottom line. The text is in a simple, sans-serif font.

JUN 2 0 2008

## 510(k) Summary of Safety and Effectiveness

## Accela System

1

510(k) Number K_081578

| Applicant: | Genesis Biosystems |
|-------------------------|-----------------------------------------------|
| Address: | 1500 Eagle Court<br>Lewisville, TX 75057 |
| Contact Person: | Stephen J. MacDonald, Director of Compliance |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Date prepared: | 01 / 16 / 2008 |
| Device Trade Name: | Accela System |
| Common Name: | Intense Pulsed Light (IPL) |
| Classification Name: | Laser Surgical Instrument 21 C.F.R § 878.4810 |
| Product Classification: | Class II device |
| Product Code: | GEX |

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Image /page/1/Picture/0 description: The image contains the text "Genesis Biosystems". The word "Genesis" is on the top line, and the word "Biosystems" is on the bottom line. There is a small graphic above the "sis" in Genesis that looks like a tree.

| Legally Marketed<br>Predicate Device: | The Accela System is substantially equivalent in terms of<br>technological characteristics, performance, intended use,<br>indications for use and operator interface to; |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Chromogenex (K053324) Sciton (K032460) Lumenis (K020839) |
| System Description: | The Accela is an Intense Pulsed Light-based medical device<br>utilizing xenon flash lamp technology to illuminate the dermis to<br>offer light based therapies as listed in the indications of use. The<br>Accela emits *light at 400nm to 1200nm via a 50mm x 50mm<br>treatment area at a repetition rate equal to or less than 0.5Hz<br>(operator selective).<br>*Light is delivered to the skin surface, while cold air integrated<br>through the handpiece, is provided to cool the epidermis. |
| Performance<br>Standards: | The device complies with the European Medical Directive<br>93/42/EEC concerning medical devices, and will comply with<br>voluntary standards UL60601-1:1996 when marketed in the U.S. |

Indications for use: Indications for Use for Fitzpatrick skin types (I to VI)

- The removal of unwanted hair and to effect stable long-term or *permanent hair t reduction. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
- The treatment of moderate inflammatory acne vulgaris ♥
- The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions including warts, scars, and striae. .
- The treatment of benign cutaneous vascular lesions, including port wine stains, � hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.

The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures.

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Image /page/2/Picture/0 description: The image contains the text "Genesis" on the top line and "Biosystems" on the second line. The word "Genesis" is larger than the word "Biosystems". There is a small graphic above the word "Genesis" that appears to be a tree.

- Reduce pain during and/or with light or laser treatment (via partial anesthesia from � cooling)
- Reduce discomfort during and/or associated with light or laser treatment �
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin 0 structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
- Allow the use of higher light or laser fluences for light or laser treatments (such as for g hair removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light or laser treatments (such as for hair removal and 0 the treatment of vascular or pigmented lesions)
- The Accela system is substantially equivalent to its predicate devices cited Conclusion: above, based on predicate similarities. Despite the differences, the skin is treated in the same manner as the preidicate devices, Intense Pulsed Light and dermal cooling.

| | Similarities | Lumenis Vasculite | Sciton BBL | Chromolight |
|--|---------------------------------|---------------------------|---------------------------|---------------------------|
| | Output Spectrum Characteristics | Similar | Similar | Similar |
| | Output Pulse Characteristics | Similar, Programmable | Similar, Programmable | Similar, Programmable |
| | Treatment Parameters | Similar, Programmable | Similar, Programmable | Similar |
| | Differences | Lumenis Vasculite | Sciton BBL | Chromolight |
| | Output Light Delivery Method | Lightguide vs. Waveguide | Lightguide vs. Waveguide | Lightguide vs. Waveguide |
| | Skin Cooling/Epidermal Coolong | Cold Gel vs. Cold Air | Gel, Contact vs. Cold Air | Contact vs. Cold Air |
| | Skin Cooling Method | Conductive vs. Convective | Conductive vs. Convective | Conductive vs. Convective |

Side Effects: In extreme cases, effects from treatment can include excessively red patches in the shape of the applicator head and blistering. If this occurs the tissue should be cooled and cared for as would normally be the case with burns to the skin, i.e. do not burst any blister formation, keep clean and covered until healed.

> If blisters form, they are usually intra-epidermal in nature and heal without scarring. Inappropriate management of blisters during the healing stage will increase the chance of scarring.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with a caduceus symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genesis Biosystems, Inc. % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, NY 11741

Re: K081578 Trade/Device Name: Accela 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: March 24, 2008 Received: June 5, 2008

JUN 2 0 2008

Dear Mr. Conry:

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 (OS) 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. Casey Conry

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 Survcillance 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 M. Mullican

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): | K081578 |
|---------------------------|----------------------------------------------------------|
| Device Name: | Accela System |
| Indications for Use: | Indications for Use for Fitzpatrick skin types (I to VI) |

- The removal of unwanted hair and to effect stable long-term or *permanent hair . reduction.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

- The treatment of moderate inflammatory acne vulgaris t
- The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles)
- . The treatment of cutaneous lesions including warts, scars, and striae.
- The treatment of benign cutaneous vascular lesions, including port wine stains, 4 hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.

The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures.

- Reduce pain during and/or with light or laser treatment (via partial anesthesia from . cooling)
- Reduce discomfort during and/or associated with light or laser treatment .
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin . structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
- Allow the use of higher light or laser fluences for light or laser treatments (such as for . hair removal and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light or laser treatments (such as for hair removal . and the treatment of vascular or pigmented lesions)

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE)<br>(Division Sign-Off) | |
|-------------------------------------------------------------------------------|-------------|
| Division of General, Restorative,<br>and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K081578 |