ACCELAWAVE SYSTEM

K082484 · Genesis Biosystems, Inc. · ONF · Sep 12, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082484
• Device Name: ACCELAWAVE SYSTEM
• Applicant: Genesis Biosystems, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Sep 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Accelawave System is indicated for: 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. 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 treatment in general aesthetic dermatologic and plastic surgery procedures. Reduce pain during and/or with light treatment (via partial anesthesia from cooling). Reduce discomfort during and/or associated with light treatment. Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation. Allow the use of higher light 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

Accelawave System is an Intense Pulsed Light (IPL) device using xenon flash lamp technology. It emits light (420nm-1200nm) via a 15mm x 45mm applicator to the skin. Device includes integrated water-cooled heat transfer network for epidermal cooling. Operated by clinicians in aesthetic/dermatologic settings. Operator selects repetition rate (≤0.5Hz) and wavelength filters based on skin type and condition. Cooling applied before, during, and after light delivery to protect epidermis, reduce pain, and allow higher fluences. Output affects clinical decision-making by enabling targeted treatment of vascular/pigmented lesions and hair reduction. Benefits include reduced thermal injury risk and side effects like scarring or pigmentation changes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison to legally marketed predicate devices and bench testing compliance with UL60601-1:1996 and European Medical Directive 93/42/EEC.

Technological Characteristics

Intense Pulsed Light (IPL) system using xenon flash lamp. Wavelength range: 420nm-1200nm. Treatment area: 15mm x 45mm. Repetition rate: ≤0.5Hz. Integrated water-cooled heat transfer network for epidermal cooling. Complies with UL60601-1:1996 and 93/42/EEC.

Indications for Use

Indicated for Fitzpatrick skin types I-VI for hair removal, acne vulgaris, benign pigmented epidermal lesions, cutaneous lesions (warts, scars, striae), and benign cutaneous vascular lesions. Integrated cooling indicated for epidermal cooling during aesthetic dermatologic/plastic surgery procedures to reduce pain, discomfort, and thermal injury risk.

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)

Reference Devices

• Lumenis Vasculite
• Sciton BBL
• Chromalight

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

Accelawave System

510(k) Number KO82484_

| Applicant: | Genesis Biosystems |
|-------------------------|-----------------------------------------------|
| Address: | 1500 Eagle Court Lewisville, TX 75057 |
| Contact Person: | Brian A. Buss, Director of Compliance |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Date prepared: | 04 / 23 / 2008 |
| Device Trade Name: | Accelawave 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: | ONF |

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Image /page/1/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is in a larger, sans-serif font, with a small tree graphic above the "sis" portion of the word. Below "Genesis" is the word "Biosystems" in a smaller font.

| Legally Marketed<br>Predicate Device: | The Accelawave 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 Accelawave 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>Accelawave emits *light at 420nm to 1200nm via a 15mm x 45mm<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 a water-cooled heat<br>transfer network cools the contacting surfaces and 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 . 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 .
- o The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions including warts, scars, and striae. 0

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Image /page/2/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is in a large, bold font, and the word "Biosystems" is in a smaller font below it. There is a small graphic above the word "Genesis" that looks like a cluster of cells.

- The treatment of benion 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 treatment in general aesthetic dermatologic and plastic surgery procedures.

- Reduce pain during and/or with light treatment (via partial anesthesia from cooling) .
- Reduce discomfort during and/or associated with light treatment .
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin . structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
- Allow the use of higher light 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)
- The Accelawave System is substantially equivalent to its predicate Conclusion: devices, based upon predicate similarities. The skin is treated in the same manner as the predicate devices, Intense Pulsed Light and dermal cooling.

| Similarities/<br>Differences | Lumenis Vasculite | Sciton BBL | Chromalight |
|--------------------------------------|------------------------------------------------------|---------------------------------|--------------------------|
| Output Spectrum<br>Characteristics | Similar | Similar | Similar |
| Output Pulse<br>Characteristics | Similar,<br>Programmable | Similar,<br>Programmable | Similar,<br>Programmable |
| Treatment<br>Parameters | Similar,<br>Programmable | Similar,<br>Programmable | Similar |
| Skin<br>Cooling/Epidermal<br>Cooling | Cold Gel vs. Cold<br>Contact Cooling<br>(difference) | Similar Cold<br>Contact Cooling | none |

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Image /page/3/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is on the top line, and the word "Biosystems" is on the second line. There is a graphic above the word "Genesis" that looks like a tree.

- 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Genesis Biosystems, Inc. % Underwriters Laboratories, Inc. Mr. Casey Conry Senior Project Engineer 1285 Walt Whitman Road Melville, New York 11747

AUG 2 6 2011

Re: K082484

Trade/Device Name: Accelawave 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: ONF

Dated: August 26, 2008 Received: August 28, 2008

Dear Mr. Conry:

This letter corrects our substantially equivalent letter of September 12, 2008.

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 (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 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A Millikan

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Genesis Biosystems. The word "Genesis" is written in a bold, sans-serif font, with a graphic above the "sis" portion of the word. Below "Genesis" is the word "Biosystems", also in a bold, sans-serif font, but slightly smaller than the word above it. The logo is black and white.

| | Indications for Use | |
|----------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K082484 | |
| Device Name: | Accelawave System | (Division Sign-Off)<br>Division of General, Restorative,<br>and Neurological Devices |
| Indications for Use for Fitzpatrick skin types (I to VI) | 510(k) Number | K082484 |

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
- . 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 treatment in general aesthetic dermatologic and plastic surgery procedures.

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

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## Indications for Use

510(k) Number (if known): K082484

awave Device Name: ACC

Indications For Use:

## Indications and Filters vs. Skin Types

| CONDITIONS | FILTER SETTINGS and WAVELENGTH RANGE | I | II | III | IV | V | VI |
|--------------------------------|--------------------------------------|----------|----------|----------|----------|----------|----------|
| Hair (course) | | 640-1200 | 640-1200 | 640-1200 | 640-1200 | 690-1200 | 690-1200 |
| Hair (fine) | | 640-1200 | 640-1200 | 640-1200 | 640-1200 | 690-1200 | 690-1200 |
| Acne Vulgaris | | 420-1200 | 420-1200 | 420-1200 | 420-1200 | 510-1200 | N/A |
| Pigmented<br>Epidermal Lesions | | | | | | | |
| a) Dyschromia | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| b) Hyperpigmentation | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| c) Melasma | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| d) Ephelides | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| Cutaneous Lesions | | | | | | | |
| a) Warts | | 420-1200 | 420-1200 | 420-1200 | 420-1200 | 420-1200 | N/A |
| b) Scars | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| c) Striae | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| Cutaneous Vascular<br>Lesions | | | | | | | |
| a) Port Wine Stain (Child) | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| b) Port Wine Stain (Adult) | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| c) Hemangiomas | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| d) Telangiectasias | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| e) Rosacea | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| f) Angiomas | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| g) Spider Angiomas | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| h) Poikiloderma | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| i) Venous Malformations | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| Leg Veins | | | | | | | |
| a) Small | | 510-1200 | 510-1200 | 510-1200 | 560-1200 | 560-1200 | N/A |
| b) Medium | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| c) Large | | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogle formxn
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K082484