(81 days)
No
The summary describes a light therapy device with different wavelengths for various dermatological and pain relief applications. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies. The testing focuses on electrical safety, electromagnetic compatibility, photobiological safety, and software verification according to general medical device software guidance, not AI/ML-specific validation.
Yes.
The device is indicated to treat dermatological conditions, moderate inflammatory acne vulgaris, periorbital wrinkles, and for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm, all of which are considered therapeutic uses. Additionally, several performance studies mentioned involve standards for "Medical electrical equipment," and specifically, "non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use."
No
The "Intended Use / Indications for Use" section describes the device as being indicated to "treat dermatological conditions," "treat moderate inflammatory acne vulgaris," "treat periorbital wrinkles," and provide "topical heating for the purpose of elevating tissue temperature" for various relief purposes. These are all therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze disease or conditions.
No
The device description explicitly states it is a "portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs)" and is "mainly made up of the base (main frame), the head (irradiator), and the lifting stand." This indicates it is a hardware device that utilizes software for control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to therapeutic applications of light energy on the body (treating acne, wrinkles, pain, stiffness, etc.). IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a portable device that emits light from LEDs and is applied externally to the body. This aligns with a therapeutic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
- Performance Studies: The performance studies mentioned focus on safety and performance standards relevant to medical electrical equipment and phototherapy devices, not the analytical performance metrics (like sensitivity, specificity, etc.) typically reported for IVD devices.
Therefore, the Photo-Therapy Device Soli-Lite LG4 Galileo is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
Blue (410-415mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830mm) and Yellow (585-595mm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and ioint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY
Device Description
The Photo-Therapy Device Soli-Lite LG4 Galileo is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:
- Red (620-633nm)
- Blue (410-415nm)
- Sequence of Yellow (585-595nm) and Infra-red (820-830nm) ●
This device is mainly made up of the base (main frame), the head (irradiator), and the lifting stand. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 following testing was performed on the Soli-Lite Galileo in accordance with the requirements of the design control regulations and established quality assurance procedures.
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
IEC60601-1-2:2014 Medical electrical equipment- Electromagnetic compatibility requirements
IEC60601-2-57:2011 Medical Electrical Equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC62471:2006 Photobiological safety of lamps and lamp systems
In addition to conformance with voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Results: Based upon the performance data, the subject device is determined to be substantially equivalent to the predicate device Aklarus Phototherapy System K083183.
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.
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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December 20, 2019
Silhouet-Tone Corporation Genevieve St-Jean Regulatory Affairs Specialist 1985 Michelin Laval, Quebec, Canada, H7L3T6
Re: K192755
Trade/Device Name: Soli-Lite LG4 Galileo 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, ILY Dated: September 25, 2019 Received: September 30, 2019
Dear Genevieve St-Jean:
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 post-marketing 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.
Purva Pandya 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Soli-Lite LG4 Galileo
Indications for Use (Describe)
Blue (410-415mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830mm) and Yellow (585-595mm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and ioint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the logo for Silhouet-Tone. The logo features a stylized swan inside of a circle above the company name. The company name is written in a sans-serif font, with a small circle to the right of the word "Tone".
Page 1 of 3
510(k) Summary
1. Submitter's Identifications
Silhouet-Tone Corporation 1985 Michelin Laval, Québec Canada, H7L 3T6
Phone: 450-687-9456 Fax: 450-687-5155
Contact Person: Geneviève St-Jean Contact Title: Regulatory Affairs Specialist Date Revised: December 19, 2019
2. Name of the Device
Device Name: Soli-Lite LG4 Galileo Usual name: Phototherapy Device Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Regulatory Class: II Product Code: GEX, ILY
3. Predicate Devices
K083183 Aklarus Phototherapy System K113668 Healite II (Reference Predicate)
4. Device Description
The Photo-Therapy Device Soli-Lite LG4 Galileo is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:
- Red (620-633nm)
- Blue (410-415nm)
- Sequence of Yellow (585-595nm) and Infra-red (820-830nm) ●
This device is mainly made up of the base (main frame), the head (irradiator), and the lifting stand. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.
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- ONE®
5. Indication for use
Blue (410-415nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
6. Summary of Substantial Equivalence
| Soli-Lite | Aklarus Phototherapy System | Healite II | |
|---|---|---|---|
| 510k Number | K192755 | K083183 | K113668 |
| Product Code | GEX, ILY | GEX, ILY | ILY |
| Indications for use | Blue (410-415nm), is generally | ||
| indicated to treat dermatological | |||
| conditions and specifically | |||
| indicated to treat moderate | |||
| inflammatory acne vulgaris. | |||
| Red (620-633nm) and Infrared | |||
| (820-830nm) Combination is | |||
| intended to emit energy in the red | |||
| and infra-red region of the | |||
| spectrum for use in dermatology | |||
| for the treatment of periorbital | |||
| wrinkles. | |||
| Combination of Infrared (820- | |||
| 830nm) and Yellow (585-595nm) is | |||
| intended to emit energy in the IR | |||
| and visible spectrum to provide | |||
| topical heating for the purpose of | |||
| elevating tissue temperature; for | |||
| the temporary relief of minor | |||
| muscle and joint pain, arthritis and | |||
| muscle spasm; relieving stiffness; | |||
| promoting the relaxation of muscle | |||
| tissue; and to temporarily increase | |||
| local blood circulation where | |||
| applied. | Blue (420nm±10nm), is generally | ||
| indicated to treat dermatological | |||
| conditions and specifically indicated to | |||
| treat moderate inflammatory acne | |||
| vulgaris. | |||
| Combination of Red (628nm ±10nm) | |||
| and Blue (420nm ±10nm) is intended | |||
| to emit energy in the red, blue regions | |||
| of the spectrum to treat dermatological | |||
| conditions, specifically indicated to treat | |||
| mild to moderate acne vulgaris. | |||
| Anti-Aging Red (628nm ±10nm) and | |||
| Anti-Aging Infrared (880nm±10nm) | |||
| Combination is intended to emit energy | |||
| in the red and infra-red region of the | |||
| spectrum for use in dermatology for the | |||
| treatment of periorbital wrinkles. | |||
| Infrared (880nm ±10nm) is intended | |||
| to emit energy in the IR spectrum to | |||
| provide topical heating for the purpose | |||
| of elevating tissue temperature; for the | |||
| temporary relief of minor muscle and | |||
| joint pain, arthritis and muscle spasm; | |||
| relieving stiffness; promoting the | |||
| relaxation of muscle tissue; and to | |||
| temporarily increase local blood | |||
| circulation where applied. | For use in temporary | ||
| relief of minor muscle | |||
| and joint pain, arthritis | |||
| and muscle spasm; | |||
| relieving stiffness; | |||
| promoting the | |||
| relaxation of muscle | |||
| tissue and to | |||
| temporarily increase | |||
| local blood circulation | |||
| where applied | |||
| Configuration | Portable | Portable | Portable |
| Components | Main frame, irradiator, lifting stand | Main frame, irradiator, lifting stand | Main frame, irradiator |
| Wavelength | Red 620-633nm | ||
| Blue 410-415nm | |||
| Infrared 820-830nm/ Yellow 585- | |||
| 595nm | Red 628nm±10nm | ||
| Blue 420nm±10nm | |||
| Infrared 880nm±10nm | Infrared 830nm/ | ||
| Yellow 590nm |
5
| SILHOUET-TONE® |
|---|
| Effective irradiance | Adjustable: 4 levels
Red: 19-47mW/cm²
Blue: 25-40mW/cm²
Infrared/yellow: 29-61mW/cm² | Red 43mW/cm²
Blue 22mW/cm²
Infrared: 35mW/cm² | Adjustable: 2 levels
Infrared/yellow: 27-
65mW/cm² |
|------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|
| Operation interface | Display screen | Display screen | Display screen |
| Operation Mode | Continuous operation | Continuous operation | Continuous operation |
| Standard | IEC60601-1
IEC60601-1-2
IEC60601-2-57
IEC62471 | IEC60601-1
IEC60601-1-2
IEC60601-2-57
IEC62471 | Unknown |
| Microprocessor Control | yes | yes | yes |
7. Substantial Equivalence
The proposed device has similar classification information, intended use, product design, and specifications as the Aklarus Phototherapy System.
Wavelengths are similar to the Aklarus Phototherapy System.
The most significant difference is the effective irradiance of the blue light between Soli-Lite LG4 Galileo and Aklarus Phototherapy System. These differences do not influence the effectiveness and safety of the device. According to the nonclinical test results, the proposed device is as effective and perform as well as the predicate device.
8. Performance Data
The following testing was performed on the Soli-Lite Galileo in accordance with the requirements of the design control regulations and established quality assurance procedures.
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
IEC60601-1-2:2014 Medical electrical equipment- Electromagnetic compatibility requirements
IEC60601-2-57:2011 Medical Electrical Equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC62471:2006 Photobiological safety of lamps and lamp systems
In addition to conformance with voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Conclusion
Based upon the performance data, the subject device is determined to be substantially equivalent to the predicate device Aklarus Phototherapy System K083183.