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.

Device Description

The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) which incorporate the use of the following accessory handpieces that are designed for specific treatments / uses: HR Handpiece - Permanent Hair reduction on all skin types; SR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions and removal of unwanted hair; VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions; AR Handpiece - Treatment of inflammatory Acne on skin types I-IV.

AI/ML Overview

This 510(k) summary does not contain sufficient information to generate the requested tables and details about acceptance criteria and a study proving device performance. The provided text is a regulatory submission for the Clareon™ and Solarus™ Pulsed Light Systems, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance study results.

Here's why the requested information cannot be extracted from the input:

No Acceptance Criteria or Reported Performance: The document explicitly states: "The differences in specifications of the Clareon™ and Solarus™ and the predicate device(s) do not result in different performances or raise new questions of safety or efficacy." This indicates that a direct performance study against specific acceptance criteria for the new devices (Clareon™ and Solarus™) was likely not conducted or reported in this summary. Instead, the argument for safety and effectiveness relies on the equivalence to previously cleared devices.
No Study Details: Consequently, there are no details about sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information because a specific performance study for these devices is not described.

Summary of what is available (and why it doesn't meet the request):

The document details the device trade names, common names, classification, legally marketed predicate devices, system description, and intended uses. The core of the submission is a "substantial equivalence" argument, meaning the devices are considered safe and effective because they are similar enough to devices already on the market that have been deemed safe and effective.

To answer your request, a document describing actual performance data, ideally from a clinical trial or bench testing, would be needed. This 510(k) summary states that no new performance data is needed because the new devices are considered equivalent to existing ones.

Summary

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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 BlvdTampa, FL 33606
Contact Person:	Anthony M. Davis
Email:	adavis@primary-technology.com
Telephone:	TEL:813-849-6362FAX:813-849-6364
Preparation Date:	September 19th , 2004
Device Trade Name:	1. Clareon™ Pulsed Light System2. Solarus™ Pulsed Light System
Common Name:	1. Clareon™2. Solarus™
Classification Name:	Laser surgical instrument for use in Generaland Plastic Surgery and in Dermatology(See: 21 CFR 878.4810)Panel: 79Product Code: GEX
Legally marketed predicate Device(s):	Palomar Medical Technologies, Inc.EsteLux™ (K020453), LuxVT™ Handpiece(K040081) and LuxG™ Handpiece(K020941)Lumenis (formerly ESC) EpiLight™(K963249) and Lumenis Family of IPLSystems { Specifically the Quantum SRmodel } (K020839)Radiancy Radiancy Acne System withClearTouch LUA (K032205)System Description: The Clareon™ andSolarus™ Pulsed Light Systems are light-based medical device(s) which incorporatethe use of the following accessory

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	handpieces that are designed for specifictreatments / uses: HR Handpiece -Permanent Hair reduction on all skin types;SR Handpiece - Photocoagulation ofdermatological vascular lesions,photothermolysis of blood vessels(facial andleg veins), and treatment of benignpigmented lesions and removal of unwantedhair; VR Handpiece - Photocoagulation ofdermatological vascular lesions,photothermolysis of blood vessels(facial andleg veins), and treatment of benignpigmented lesions; AR Handpiece -Treatment of inflammatory Acne on skintypes I-IV.
Intended use:	The Clareon™ and Solarus™ Pulsed LightSystems are light-based medical device(s)designed for Permanent Hair reduction ,Photocoagulation of dermatological vascularlesions, photothermolysis of bloodvessels(facial and leg veins), and treatmentof benign pigmented lesions on all skintypes. Treatment of inflammatory Acne onskin types I-IV.
Performance Data:	The differences in specifications of theClareon™ and Solarus™ and the predicatedevice(s) do not result in differentperformances or raise new questions ofsafety or efficacy.
Conclusion:	Based on the foregoing, the Clareon™ andSolarus™ Pulsed Light Systems withaccessory handpieces are substantiallyequivalent to the legally-marketed predicatedevice(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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.