CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES

K043319 · Novalis Medical, LLC · GEX · Dec 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K043319
• Device Name: CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
• Applicant: Novalis Medical, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) designed for Permanent Hair reduction , Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions on all skin types. Treatment of inflammatory Acne on skin types I-IV.

Device Story

Clareon™ and Solarus™ are light-based systems utilizing interchangeable handpieces for dermatological procedures. Handpieces include HR (hair reduction), SR (vascular/pigmented lesions/hair), VR (vascular/pigmented lesions), and AR (inflammatory acne). Systems deliver pulsed light energy to target tissues; principle of operation involves selective photothermolysis. Devices are intended for clinical use by healthcare professionals. Output consists of controlled light pulses; clinical decision-making relies on provider assessment of skin type and lesion characteristics. Benefits include non-invasive treatment of vascular/pigmented lesions, hair reduction, and acne management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance data indicating that differences in specifications do not result in different performance or raise new safety/efficacy concerns.

Technological Characteristics

Light-based medical system; utilizes interchangeable handpieces (HR, SR, VR, AR) for specific dermatological applications. Energy source is pulsed light. System is designed for clinical use. No specific materials, software architecture, or connectivity standards are detailed in the provided documentation.

Indications for Use

Indicated for permanent hair reduction on all skin types; photocoagulation of dermatological vascular lesions, photothermolysis of facial/leg blood vessels, and treatment of benign pigmented lesions on all skin types; and treatment of inflammatory acne on skin types I-IV.

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 Medical Technologies, Inc. EsteLux™ (K020453)
• LuxVT™ Handpiece (K040081)
• LuxG™ Handpiece (K020941)
• Lumenis EpiLight™ (K963249)
• Lumenis Quantum SR model (K020839)
• Radiancy Acne System with ClearTouch LUA (K032205)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness for the Clareon™ and Solarus™ pulsed light devices by Primary Technology is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Novalis Medical, LLC |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1719 W. Kennedy Blvd<br>Tampa, FL 33606 |
| Contact Person: | Anthony M. Davis |
| Email: | [e-mail] |
| Telephone: | TEL:<br>813-849-6362<br>FAX:<br>813-849-6364 |
| Preparation Date: | September 19th , 2004 |
| Device Trade Name: | 1. Clareon™ Pulsed Light System<br>2. Solarus™ Pulsed Light System |
| Common Name: | 1. Clareon™<br>2. Solarus™ |
| Classification Name: | Laser surgical instrument for use in General<br>and Plastic Surgery and in Dermatology<br>(See: 21 CFR 878.4810)<br>Panel: 79<br>Product Code: GEX |
| Legally marketed predicate Device(s): | Palomar Medical Technologies, Inc.<br>EsteLux™ (K020453), LuxVT™ Handpiece<br>(K040081) and LuxG™ Handpiece<br>(K020941)<br>Lumenis (formerly ESC) EpiLight™<br>(K963249) and Lumenis Family of IPL<br>Systems { Specifically the Quantum SR<br>model } (K020839)<br>Radiancy Radiancy Acne System with<br>ClearTouch LUA (K032205)<br>System Description: The Clareon™ and<br>Solarus™ Pulsed Light Systems are light-<br>based medical device(s) which incorporate<br>the use of the following accessory |

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| | handpieces that are designed for specific<br>treatments / uses: HR Handpiece -<br>Permanent Hair reduction on all skin types;<br>SR Handpiece - Photocoagulation of<br>dermatological vascular lesions,<br>photothermolysis of blood vessels(facial and<br>leg veins), and treatment of benign<br>pigmented lesions and removal of unwanted<br>hair; VR Handpiece - Photocoagulation of<br>dermatological vascular lesions,<br>photothermolysis of blood vessels(facial and<br>leg veins), and treatment of benign<br>pigmented lesions; AR Handpiece -<br>Treatment of inflammatory Acne on skin<br>types I-IV. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | The Clareon™ and Solarus™ Pulsed Light<br>Systems are light-based medical device(s)<br>designed for Permanent Hair reduction ,<br>Photocoagulation of dermatological vascular<br>lesions, photothermolysis of blood<br>vessels(facial and leg veins), and treatment<br>of benign pigmented lesions on all skin<br>types. Treatment of inflammatory Acne on<br>skin types I-IV. |
| Performance Data: | The differences in specifications of the<br>Clareon™ and Solarus™ and the predicate<br>device(s) do not result in different<br>performances or raise new questions of<br>safety or efficacy. |
| Conclusion: | Based on the foregoing, the Clareon™ and<br>Solarus™ Pulsed Light Systems with<br>accessory handpieces are substantially<br>equivalent to the legally-marketed predicate<br>device(s). |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Novalis Medical, LLC C/o Mr. Daniel W. Lehtonen Responsible Third Pary Official 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K043319

Trade/Device Name: Clareon™ Pulsed Light System and Accessories, Solarus™ Pulsed Light System and Accessories 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: November 20, 2004 Received: December 2, 2004

Dear Mr. Lehtonen:

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 - Mr. Daniel W. Lehtonen

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 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provoost

Celia M. Witten, Ph.D., M.D. 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):

#### Device Name:

## Clareon™ Pulsed Light System Solarus™ Pulsed Light System

### Indications for Use:

The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) intended for use with the following:

HR Handpiece - Permanent hair reduction.

AR Handpiece - Treatment of inflammatory acne.

VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions.

SR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions. Removal of unwanted hair.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter-Use (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)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________