(15 days)
Not Found
No
The summary describes a light-based medical device with different handpieces for various dermatological treatments. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance study summary focuses on equivalence to predicate devices based on specifications, not on algorithmic performance metrics.
Yes
The device is intended for medical treatments such as permanent hair reduction, treatment of inflammatory acne, photocoagulation of dermatological vascular lesions, and treatment of benign pigmented lesions, which are therapeutic applications.
No
The device descriptions and intended uses uniformly specify treatments (hair reduction, acne treatment, lesion photocoagulation) rather than diagnosis. There is no mention of diagnostic functions, measurements, or analysis of patient conditions to determine diseases or conditions.
No
The device description explicitly states it is a "light-based medical device(s)" and mentions "accessory handpieces," indicating it includes hardware components that deliver light energy for treatment.
Based on the provided information, the Clareon™ and Solarus™ Pulsed Light Systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on the body (hair reduction, acne, vascular lesions, pigmented lesions). IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the light-based technology and handpieces used for direct treatment of the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Clareon™ and Solarus™ Pulsed Light Systems are therapeutic medical devices, not IVD devices.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and leg veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K020453, K040081, K020941, K963249, K020839, K032205
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
| Tampa, FL 33606 | |
| Contact Person: | Anthony M. Davis |
| Email: | adavis@primary-technology.com |
| Telephone: | TEL: |
| 813-849-6362 | |
| FAX: | |
| 813-849-6364 | |
| Preparation Date: | September 19th , 2004 |
| Device Trade Name: | 1. Clareon™ Pulsed Light System |
- Solarus™ Pulsed Light System |
| Common Name: | 1. Clareon™ - Solarus™ |
| Classification Name: | Laser surgical instrument for use in General
and Plastic Surgery and in Dermatology
(See: 21 CFR 878.4810)
Panel: 79
Product 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 IPL
Systems { Specifically the Quantum SR
model } (K020839)
Radiancy Radiancy Acne System with
ClearTouch LUA (K032205)
System Description: The Clareon™ and
Solarus™ Pulsed Light Systems are light-
based medical device(s) which incorporate
the use of the following accessory |
1
| | 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. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Performance Data: | 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. |
| Conclusion: | Based on the foregoing, the Clareon™ and
Solarus™ Pulsed Light Systems with
accessory handpieces are substantially
equivalent to the legally-marketed predicate
device(s). |
2
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.
3
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
4
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_________________________________________________________________________________________________________________________________________________________________