PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS

K073477 · Photonova Ofsweden AB · GEX · May 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073477
• Device Name: PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
• Applicant: Photonova Ofsweden AB
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Photonova Pulsed Light System is indicated for the following: • The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction • The treatment of benign pigmented lesions, including lentigines, nevi, melasma and café-au-lait • The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins • Treatment of inflammatory acne (acne vulgaris)

Device Story

Device delivers pulsed light (wavelengths ≥515 nm) for dermatological procedures. System comprises cabinet (power supply, cooling system, microcontroller), umbilical, and handpiece (waveguide). Operated by clinicians in dermatology/plastic surgery settings. Microcontroller manages energy delivery; light pulses target specific chromophores in skin/hair follicles. Clinical benefit includes hair reduction and lesion/acne treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Pulsed light system; wavelengths ≥515 nm. Components: cabinet (power supply, cooling, microcontroller), umbilical, handpiece with waveguide. Energy source: electrical power converted to pulsed light. Software-controlled via internal microcontroller.

Indications for Use

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

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

• OmniLight (K032191)
• Lux V (K040081)
• StarLux (K03349)

Submission Summary (Full Text)

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510(K) Summary
PhotoNova Family of Pulsed Light Systems
K073477

This 510(K) Summary of safety and effectiveness for the Photonova Family of Pulsed Light Systems is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Photonova of Sweden AB | |
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| Address: | Hulda Lindgrens Gata 6C<br>42131 Vastra Frolunda<br>SWEDEN | |
| Contact Person: | Anders Bonde | |
| Telephone / Fax / Email | 46-31-742-1281- Phone<br>[e-mail] | |
| Preparation Date: | October 31, 2007 | |
| Device Trade Name: | Photonova Family of Pulsed Light Systems | |
| Common Name: | Intense Pulsed Light | |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | OmniLight K032191<br>Lux V K040081<br>StarLux K03349 | |
| Description of the Photonova Family of<br>Pulsed Light Systems | The Photonova Pulsed Light Systems delivers pulsed light at<br>wavelengths starting at 515 nanometers. The device consists<br>of three interconnected sections: The cabinet which houses<br>the power supply, the cooling system and the microcontroller,<br>the umbilical to the handpiece, and the handpiece, which<br>houses the waveguide | |
| Intended use of the Photonova Family of<br>Pulsed Light Systems | The Photonova Pulsed Light System is indicated for the<br>following:<br>• The removal of unwanted hair form all skin types and<br>to effect stable long-term or permanent hair<br>reduction<br>• The treatment of benign pigmented lesions, including<br>lentigines, nevi, melasma and café-au-lait<br>• The treatment of vascular lesions, including port wine<br>stains, hemangiomas, angiomas, ttelangiectasias,<br>rosacea, facial and leg veins<br>• Treatment of inflammatory acne (acne vulgaris) | |

Performance Data:

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## 510(K) Summary PhotoNova Family of Pulsed Light Systems

Conclusion:

The PhotoNova Family of Pulsed Light Systems is substantially equivalent to other existing pulsed light systems in commercial distribution in Dermatology and Plastic Surgery.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Photonova of Sweden AB % Ms. Connie Hoy 908 Stetson Street Woodland, California 95776

Re: K073477

Trade/Device Name: PhotoNova Family of Pulsed Light Systems 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: April 30, 2008 Received: May 5, 2008

Dear Ms. Hoy:

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 - Ms. Connie Hoy

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. Millman

- 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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#### Attachment 4 Indications For Use Statement

510(k) Number (if Known):

### Device Name: PhotoNova Family of Pulsed Light Systems

Indications for Use:

Prescrip

The PhotoNova Family of Pulsed Light Systems is designed for use in dermatology applications including:

- · The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction
- · The treatment of benign pigmented lesions, including lentigines, nevi, melasma and caféau-lait
- · The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins
- · Treatment of inflammatory acne (acne vulgaris)

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Concurrence of EURH Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K023477 |
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| ption Use | X | OR | Over-The-Counter Use |
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