(23 days)
Not Found
No
The description mentions "self-diagnostic algorithms" and an "embedded processor and software" for controlling laser delivery and monitoring status, but these are standard features for medical devices and do not indicate the use of AI or ML. There is no mention of learning, adaptation, or complex pattern recognition beyond basic operational control.
Yes.
The device is used in dermatological procedures for the coagulation of soft tissue and general skin resurfacing, which are therapeutic medical procedures.
No.
The device is indicated for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures, which are therapeutic rather than diagnostic actions. It also uses self-diagnostic algorithms for its own operation, not to diagnose a patient.
No
The device description clearly states it is a laser system comprised of hardware components (console, handpieces, treatment tip, credit key) in addition to software.
Based on the provided information, the CLEAR + BRILLIANT TOUCH® System is not an In Vitro Diagnostic (IVD) device.
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 skin.
- Device Description: The device is a laser system that delivers energy to the skin for resurfacing. It involves physical interaction with the patient's body.
- Anatomical Site: The anatomical site is the "Skin," which is a part of the living body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information about a person's health. The CLEAR + BRILLIANT TOUCH® System does not perform this function.
The device is a therapeutic device used for treating the skin directly, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Product codes
GEX, ONG
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:
-
- Console
-
- Handpieces: 1440nm and 1927nm (Perméa) handpieces
-
- Treatment Tip
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The CLEAR+BRILLIANT TOUCH® Laser System passed all the applicable standards testing (ANSI/AAMI ES 60601-1, IEC/EN 60601-1-2 Ed.4.0, IEC 60601-2-22:2012, IEC 60825-1:2014 Edition 3.0, ISO 10993-1:2018, EN/ISO-10993-5: 2009, ISO 10993-10:2013, 21 CFR Part 820, ISO 13485, EN ISO 13485:2016, EN ISO 14971:2019, EN 62304:2015, EN/IEC 62366-1 b: 2015 Edition 1.0 b cor.1: 2016, IEC 60601-1-6:2013, ANSI/AAMI HE75: 2009 (R)2018, ISTA testing standards). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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.
1
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
2
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 80 |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
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 +
4
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:
-
- Console
-
- Handpieces: 1440nm and 1927nm (Perméa) handpieces
-
- Treatment Tip
-
- 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.
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 System
is intended for dermatological
procedures requiring the
coagulation of soft tissue and | The CLEAR + BRILLIANT TOUCH®
System is indicated for use in
dermatological procedures requiring | Equivalent |
| | general skin resurfacing | the coagulation of soft tissue and
general 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 Watts
1927nm: 0.9 Watts | 1440nm: 2.5 Watts
1927nm: 0.9 Watts | Equivalent |
| Electrical | 110-240V- AC | 110-240V- AC | Equivalent |
| Skin Cooling
Method | Passive Conductance | Passive Conductance | Equivalent |
| Main Components | Console, hand piece(s), Treatment
Tips | Console, hand piece(s), Vented
Treatment Tips | Equivalent |
| Laser Activation in
Hand or Foot
Activated | Hand switch activated | Hand switch activated | Equivalent |
| Treatment Tip | | | |
| Tip Design | No vents | Vented | Difference |
| | | | Difference, but
no new
biocompatibility
safety concerns. |
| Material | Polycarbonate GE HPH4404,
translucent grey (Polycarbonate) | Americhem FRPC300 L32721, grey
tinted (Polycarbonate) | |
| Console | | | |
| User Interface | LCD | Touchscreen Technology for user
interaction | Difference |
| Number of
handpiece cradles | 1 | 2 | Difference |
| Handpiece to
console connection | Manually fastened screws | Mechanical Latch | Difference |
| Number of
Handpieces
connected during
operation | 1 | 2 | Difference |
| Treatment
Authentication | | | |
| Authenticator | SmartCard | Credit Key | Difference |
| Authenticator Use | Different SmartCard for different
Handpieces | Same credit key for both Handpieces | Difference |
| Dimensions | | | |
| Console
Dimensions
(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 two
stowed handpieces) | Difference |
| Hand Piece
Dimensions
(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 of
system with two stowed handpieces
and 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 punctures
1440nm: 40-60 micro thermal zone punctures per cm2 per pass | 1927nm: 20-40 microthermal zone punctures
1440nm: 40-60 micro thermal zone punctures per cm2 per pass | Equivalent |
| Treatment coverage based on Lesion
Cross Section and Density | Approximately 4% to 12% | Approximately 4% to 12% | Equivalent |
| Treatment width | 10 mm | 10 mm | Equivalent |
| Operating
Conditions | | | |
| Operating
Conditions:
Temperature | 59 to 86-degree F (15 to 30 degree C) | 59 to 86-degree F (15 to 30 degree C) | Equivalent |
| Operating
Conditions:
Relative Humidity | 30-75%, Non-condensing | 30-75%, Non-condensing | Equivalent |
| Operating
Conditions:
Altitude |