(49 days)
Not Found
No
The description focuses on the laser technology and embedded processor for control, with no mention of AI or ML capabilities.
Yes
The device is a non-ablative laser system designed for dermatological procedures and general skin resurfacing, which are therapeutic interventions.
No
The device is described as a non-ablative laser system for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states it is a "non-ablative laser system" with a "laser source in the hand piece" and a "console," indicating it is a hardware-based medical device that utilizes software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures." This describes a direct treatment applied to the patient's body.
- Device Description: The description details a laser system that delivers energy to tissue through a handpiece and treatment tips. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining biological samples.
This device is clearly designed for therapeutic use on the patient's skin, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Clear + Brilliant Laser System is intended for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
Device Description
The Clear + Brilliant™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures.
The Clear + Brilliant Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece.
The original Clear + Brilliant Laser System has a single hand piece containing a 1440 nm diode laser. A second hand piece with a 1927 nm diode laser has been added to the system as a line extension which provides an additional laser wavelength option at the same low power settings of the predicate Clear + Brilliant Laser System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
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.
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.
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SECTION 5: 510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
APR - 2 2012
1. General Information
Date of Submission: March 20, 2012
Submitted By:
Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545
Contact Person:
Kristine Foss V.P., Regulatory, Clinical & Quality 510-780-4657 (Direct Phone) 510-780-4857 Fax kfoss@solta.com
2. Trade/Proprietary Name of Device:
| Trade Name: | Clear + Brilliant™ Laser System |
|---|---|
| Common Name: | Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code: | GEX/ONG |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |
3. Legally Marketed Predicate Devices for Claimed Equivalence:
Clear + Brilliant™ Laser System Name: 510(k) #: K110349 Fraxel® DUAL 1550/1927 Laser System Name: K101490 510(k) #:
4. Device Description
The Clear + Brilliant™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures.
The Clear + Brilliant Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece.
1
The original Clear + Brilliant Laser System has a single hand piece containing a 1440 nm diode laser. A second hand piece with a 1927 nm diode laser has been added to the system as a line extension which provides an additional laser wavelength option at the same low power settings of the predicate Clear + Brilliant Laser System.
5. Intended Use:
The Clear + Brilliant Laser System is intended for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
6. Technological Characteristics:
The Clear + Brilliant Laser System with an addition of the 1927 nm diode laser is similar to the predicate device in design specification, output energy, and delivery system. They are both laser instruments designed to produce laser energy for soft tissue coagulation and general skin resurfacing during dermatological procedures. The modifications to handpiece hardware, circuitry, and laser wavelength do not significantly affect the safety or effectiveness of the device. The system was evaluated and found compliant with IEC 60601-1 and 60601-1-4 for electrical safety, IEC 60601-1-2 for EMI/EMC, ISO 60825 for laser classification/safety, and 10993-1 for biocompatibility of the treatment tips. Verification and validation data show that the device meets all product specifications.
7. Performance Data:
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
8. Conclusion:
By virtue of the design, materials function and intended use, the Clear + Brilliant Laser System is as safe, as effective and performs as well as or better than the predicate device. In establishing substantial equivalence to the predicate device, Solta Medical evaluated the indications for use, product specifications, and energy requirements of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an abstract symbol resembling an eagle or bird in flight, composed of thick, stylized lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 2 2012
Solta Medical, Inc. % Ms. Kristine Foss V.P. Regulatory, Clinical & Quality 25881 Industrial Boulevard Hayward, California 94545
Re: K120433
Trade/Device Name: Clear - Brilliant™ Laser 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: ONG Dated: March 20, 2012 Received: March 22, 2012
Dear Ms. Foss:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Kristine Foss
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); 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/Safetv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Mark N. Melloan
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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Indications for Use
510(k) Number (if known): K120443
Clear + Brilliant™ Laser System Device Name:
Indications For Use:
Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil H. Dale Soroka
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number