The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

Device Description

The CLEAR + BRILLIANT TOUCH® Laser System is the second generation of the Clear+Brilliant line of products. Clear+Brilliant products use non-ablative laser designed for use in dermatological procedures intended to improve the appearance of a patient's skin. The system incorporates self-diagnostic algorithms to ensure its correct operation. The CLEAR + BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin.

CLEAR + BRILLIANT TOUCH® Laser System is comprised of four sub-systems:

1. Console
1. Handpieces: 1440nm and 1927nm (Perméa) handpieces
1. Treatment Tip
1. Credit Key

The console and up to two handpieces are connected mechanically and electrically by an umbilical cable. The treatment tip is mechanically and magnetically secured to the handpiece. All components must be properly connected and fully functional for the system to be operable. The system will not permit laser energy output until the treatment tip is in contact with the patient's skin.

The embedded processor and software control the precise delivery of the fractional laser treatment by directing the electrical and mechanical components that determine the position, spacing, and focus of the optical output. The processor and software also monitor the status of a treatment and the system and present this information to the operator on the touchscreen.

The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero.

The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, reported device performance, or a clinical study for the CLEAR+BRILLIANT TOUCH® Laser System as it would for an AI/ML powered device. This document is a 510(k) premarket notification for a medical device that utilizes laser technology for dermatological procedures, not an AI/ML diagnostic or prognostic tool.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

Type of Device: The CLEAR+BRILLIANT TOUCH® Laser System is a physical laser device, not a software algorithm that performs diagnostics or prognostics. Therefore, the typical acceptance criteria and study designs (like standalone performance, MRMC studies, ground truth establishment) for AI/ML devices do not apply.
510(k) Clearance: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. The focus is on comparing technological characteristics, safety standards compliance, and non-clinical performance (like electrical safety, electromagnetic compatibility, biocompatibility, and software validation), rather than a clinical effectiveness study with specific diagnostic performance metrics like sensitivity or specificity.

However, I can extract the relevant information that is present in the document.

Information Present in the Document:

1. A table of acceptance criteria and the reported device performance:

The document lists various non-clinical performance tests and standards to which the device must conform, and it states that the device "passed all the above applicable standards testing." These standards serve as the "acceptance criteria" for safety and basic performance.

Document No.	Document Title	Reported Device Performance
ANSI/AAMI ES 60601-1(2005) + AMD (2012) and AAMI STD ES60601-1	Medical electrical equipment – Part 1: General requirements for basic safety and essential performance	Passed, demonstrating compliance
IEC/EN 60601-1-2 Ed.4.0 (2014)	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests	Passed, demonstrating compliance
IEC 60601-2-22:2012, Edition 3.1	Medical Electrical Equipment—Part 2-2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.	Passed, demonstrating compliance
IEC 60825-1:2014 Edition 3.0	Safety of laser products - Part 1: Equipment classification and requirements.	Passed, demonstrating compliance
ISO 10993-1:2018	Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process	Passed, demonstrating compliance (for biocompatibility of materials)
EN/ISO-10993-5: 2009	International Organization for Standardization (ISO) 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.	Passed, demonstrating compliance (for biocompatibility of materials)
ISO 10993-10:2013	International Organization for Standardization (ISO) 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (2010).	Passed, demonstrating compliance (for biocompatibility of materials)
21 CFR Part 820	FDA Quality Systems Regulation	Compliance indicated by 510(k) submission implying adherence to QSR
ISO 13485	Medical Devices – Quality Management Systems	Compliance indicated by 510(k) submission implying adherence to QMS
EN ISO 13485:2016	Medical devices—Quality management systems—Requirements for regulatory purposes	Compliance indicated by 510(k) submission implying adherence to QMS
EN ISO 14971:2019	Medical Devices—Application of risk management to medical devices	Compliance indicated by 510(k) submission implying adherence to risk management
EN 62304:2015	Medical device software—Software life cycle processes	Compliance indicated by inclusion of software in the device
EN/IEC 62366-1 b: 2015 Edition 1.0 b cor.1: 2016	Medical devices - Application of usability engineering to medical devices	Compliance indicated by documentation
IEC 60601-1-6:2013, Edition 3.1	Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.	Compliance indicated by documentation
ANSI/AAMI HE75: 2009 (R)2018 (Reference Standard)	Human factors engineering - Design of medical devices	Compliance indicated by documentation
ISTA testing standards	International Safe Transit Association; Packaging integrity performance tests; General test standards are ISTA 1A, 2A, and 3A per transport environment.	Passed, demonstrating packaging integrity

The overall performance evaluation states: "The product performance testing demonstrates that the functional requirements have been met and that CLEAR+BRILLIANT TOUCH® Laser System is equivalent to the predicate device."

The following requested information is NOT applicable or NOT found in the provided document, as it pertains to AI/ML or clinical efficacy studies that are typically not part of a 510(k) submission for this type of laser device:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a laser device's non-clinical performance testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for a laser device's safety and performance involves engineering and standards compliance, not medical expert interpretation of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a laser device, not an AI/ML-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For this laser device, the "ground truth" for non-clinical testing is adherence to established engineering, electrical, biocompatibility, and safety standards.
The sample size for the training set: Not applicable (no AI/ML training set).
How the ground truth for the training set was established: Not applicable (no AI/ML training set).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 29, 2022

Solta Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K223647

Trade/Device Name: CLEAR+BRILLIANT TOUCH® 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: Class II Product Code: GEX, ONG Dated: December 5, 2022 Received: December 6, 2022

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Carr -S

for Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223647

Device Name CLEAR+BRILLIANT TOUCH® Laser System

Indications for Use (Describe)

The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over The Counter Use (21 CFR 80
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| X | Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Summary Preparation Date: December 27, 2022

1. 510(k) Owner Name and Address

Solta Medical, Inc. 11720 North Creek Parkway N, Suite 100 Bothell, WA 98011 USA

Submitter & Primary Contact: Aditi Chaubal (primary contact) Phone: 425-420-2350 Fax: 1-425-420-2300 aditi.chaubal@solta.com

2. I dentification of Subject Device

Trade Name:	CLEAR+BRILLIANT TOUCH® Laser System
Common Name:	Powered Laser Surgical Instrument with Microbeam\Fractional Output
Regulation Number:	21 CFR 878.4810
Product code:	GEX, ONG
Device Panel:	General & Plastic Surgery
Device Classification:	Class II

3. Predicate Device

Trade Name:	CLEAR+BRILLIANT® Laser System
Common Name:	Powered Laser Surgical Instrument with Microbeam\Fractional Output
Regulation Number:	21 CFR 878.4810
Product code:	GEX, ONG
Device Panel:	General & Plastic Surgery
Device Classification:	Class II
510(k) Number:	K120433, K110349

4. Device Description

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BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin.

CLEAR + BRILLIANT TOUCH® Laser System is comprised of four sub-systems:

1. Console
1. Handpieces: 1440nm and 1927nm (Perméa) handpieces
1. Treatment Tip
1. Credit Key

The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero.

The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.

5. Indications for Use

"The CLEAR + BRILLIANT TOUCH® Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures."

6. Comparison of Technological Characteristics

The CLEAR+BRILLIANT TOUCH® Laser System and accessories share similar device operation, overall technical and functional capabilities. The design, function and treatment delivery are equivalent to the predicate device.

	CLEAR+BRILLIANT(Predicate – K120433)	CLEAR+BRILLIANT Touch®(Subject Device)
Feature			Remark
Product Code &Reg. Classification	GEX/ONG, Class II	GEX/ONG, Class II	Equivalent
Laser Classification	Class III-R	Class III-R	Equivalent
Indications for Use	The Clear + Brilliant Laser Systemis intended for dermatologicalprocedures requiring thecoagulation of soft tissue and	The CLEAR + BRILLIANT TOUCH®System is indicated for use indermatological procedures requiring	Equivalent
	general skin resurfacing	the coagulation of soft tissue andgeneral skin resurfacing procedures.
HandPiece
Laser Type	Diode Laser	Diode Laser	Equivalent
	1440	1440
Wavelength, nm	1927	1927	Equivalent
Peak Laser Power,W	1440nm: 2.5 Watts1927nm: 0.9 Watts	1440nm: 2.5 Watts1927nm: 0.9 Watts	Equivalent
Electrical	110-240V- AC	110-240V- AC	Equivalent
Skin CoolingMethod	Passive Conductance	Passive Conductance	Equivalent
Main Components	Console, hand piece(s), TreatmentTips	Console, hand piece(s), VentedTreatment Tips	Equivalent
Laser Activation inHand or FootActivated	Hand switch activated	Hand switch activated	Equivalent
Treatment Tip
Tip Design	No vents	Vented	Difference
			Difference, butno newbiocompatibilitysafety concerns.
Material	Polycarbonate GE HPH4404,translucent grey (Polycarbonate)	Americhem FRPC300 L32721, greytinted (Polycarbonate)
Console
User Interface	LCD	Touchscreen Technology for userinteraction	Difference
Number ofhandpiece cradles	1	2	Difference
Handpiece toconsole connection	Manually fastened screws	Mechanical Latch	Difference
Number ofHandpiecesconnected duringoperation	1	2	Difference
TreatmentAuthentication
Authenticator	SmartCard	Credit Key	Difference
Authenticator Use	Different SmartCard for differentHandpieces	Same credit key for both Handpieces	Difference
Dimensions
ConsoleDimensions(Heights, Width,Depth)	17.62"x12.47"x 8.03"	12.5" W x 11.25" H x 11" D(dimensions of the system with twostowed handpieces)	Difference
Hand PieceDimensions(Height, Width,Depth)	8.3"x3.1"x2.0"	8.3"x3.1"x2.0"	Equivalent
Weight	Approximately 15 lbs.	Approximately 15.6 lbs. (weight ofsystem with two stowed handpiecesand credit key installed on console)	Equivalent
Hand Piece Weight	330 grams or approximately 0.7 lbs.	330 grams or approximately 0.7 lbs.	Equivalent
Treatment
Density	1927nm: 20-40 microthermal zone punctures1440nm: 40-60 micro thermal zone punctures per cm2 per pass	1927nm: 20-40 microthermal zone punctures1440nm: 40-60 micro thermal zone punctures per cm2 per pass	Equivalent
Treatment coverage based on LesionCross Section and Density	Approximately 4% to 12%	Approximately 4% to 12%	Equivalent
Treatment width	10 mm	10 mm	Equivalent
OperatingConditions
OperatingConditions:Temperature	59 to 86-degree F (15 to 30 degree C)	59 to 86-degree F (15 to 30 degree C)	Equivalent
OperatingConditions:Relative Humidity	30-75%, Non-condensing	30-75%, Non-condensing	Equivalent
OperatingConditions:Altitude	<10, 000 Feet (<3,075 Meters)	<10, 000 Feet (<3,075 Meters)	Equivalent

Summary of the technological characteristics

| 510(k) Summary

PREMARKET NOTIFICATION TRADITIONAL 510(K): CLEAR+BRILLIANT TOUCH® LASER SYSTEM

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3 | 510(k) Summary

3 | 510(k) Summary
PREMARKET NOTIFICATION TRADITIONAL 510(K): CLEAR+BRILLIANT TOUCH® LASER SYSTEM

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The CLEAR+BRILLIANT TOUCH® Laser System is developed on the Solta System Controller (SC) platform. This platform comprises hardware, firmware, and software (SW) which are common across different Solta products. This architecture is consistent with the Solta New Product architecture. The software portion of this architecture is split into two portions.

System controller software (SC)

1. CLEAR+BRILLIANT TOUCH® Laser System software
  The System Controller software is responsible for Operating System (OS) functions and common product functions (across products such as infrastructure). This is a software component that implements common functions across products implemented at Solta Medical. This is shared as source code between the various products and will be included in the CLEAR+BRILLIANT TOUCH® Laser System software build.

7. Non-Clinical Performance Testing

As with the predicate device, safety tests of the CLEAR+BRILLIANT TOUCH® Laser System has also demonstrated its compliance with applicable requirements of the following standards:

Document No.	Document Title
ANSI/AAMI ES 60601-1(2005) + AMD (2012) andAAMI STD ES60601-1.	Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance

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Document No.	Document Title
IEC/EN 60601-1-2 Ed.4.0(2014)	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
IEC 60601-2-22:2012,Edition 3.1	Medical Electrical Equipment—Part 2-2: Particular requirementsfor basic safety and essential performance of surgical, cosmetic,therapeutic and diagnostic laser equipment.
IEC 60825-1:2014 Edition3.0	Safety of laser products - Part 1: Equipment classification andrequirements.

Biocompatibility

Document No.	Document Title
ISO 10993-1:2018	Biological evaluation of medical devices -- Part 1: Evaluation andtesting within a risk management process
EN/ISO-10993-5: 2009	International Organization for Standardization (ISO) 10993-5,Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity.
ISO 10993-10:2013	International Organization for Standardization (ISO) 10993-10,Biological evaluation of medical devices - Part 10: Tests for irritationand skin sensitization (2010).

Management

Document No.	Document Title
21 CFR Part 820	FDA Quality Systems Regulation
ISO 13485	Medical Devices – Quality Management Systems
EN ISO 13485:2016	Medical devices—Quality management systems—Requirements forregulatory purposes
EN ISO 14971:2019	Medical Devices—Application of risk management to medicaldevices
EN 62304:2015	Medical device software—Software life cycle processes

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Document No.	Document Title
EN/IEC 62366-1 b: 2015 Edition1.0 b cor.1: 2016	Medical devices - Application of usability engineering tomedical devices
IEC 60601-1-6:2013, Edition 3.1	Medical electrical equipment -- Part 1-6: General requirementsfor basic safety and essential performance - Collateral standard:Usability.
ANSI/AAMI HE75: 2009(R)2018 (Reference Standard)	Human factors engineering - Design of medical devices

Human Factors and Usability Engineering

Safe Transit

Document No.	Document Title
ISTA testing standards	International Safe Transit Association; Packaging integrity performancetests; General test standards are ISTA 1A, 2A, and 3A per transportenvironment.

The CLEAR+BRILLIANT TOUCH® Laser System passed all the above applicable standards testing. The product performance testing demonstrates that the functional requirements have been met and that CLEAR+BRILLIANT TOUCH® Laser System is equivalent to the predicate device.

8. Conclusion

The CLEAR+BRILLIANT TOUCH® Laser System shares the same design and functional features as the predicate device, including the laser type, wavelength and device design. Therefore, the CLEAR+BRILLIANT TOUCH® Laser System is substantially equivalent to the previously cleared version of the CLEAR+BRILLIANT Laser System.

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.