(95 days)
The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, blue light modules are indicated to treat mild to moderate inflammatory acne.
The Tanda Mini Skincare System is a smaller version of its predicate device (K080951) that shares the same principal features and characteristics as the predicate. Both the devices are cordless, handheld units that have a single on/off push button that activates the units. The Tanda Mini Skincare System uses the same technology to deliver blue light at 414 nm to the treatment surface via light emitting diodes (LEDs) as its predicate. Furthermore, there have been no modifications to the safety features of its predicate, which includes a sensor for skin contact and temperature as well as sound indicators. The only changes made in the Tanda Mini Skincare System compared to the previously cleared predicate relates to additional ergonomic features such as a textured treatment surface, and a vibration indicator to signify the treatment is in progress. Furthermore, the total energy dose, dose rate, and treatment regimen remain the same as the previously cleared predicate device.
The provided text describes a 510(k) summary for the Tanda Mini Skincare System. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a new clinical study to establish efficacy. Therefore, much of the requested information regarding a study proving acceptance criteria for device performance is not explicitly available in the provided document.
Here's a breakdown of the information that can be extracted, and where limitations exist:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific acceptance criteria for clinical performance (e.g., reduction in acne lesion count) or a direct comparison of such performance between the Tanda Mini Skincare System and its predicate. Instead, the acceptance criteria are related to engineering and safety standards.
| Acceptance Criteria Category | Predicate Device (K080591) | Tanda Mini Skincare System Performance (as demonstrated by testing) |
|---|---|---|
| Technological Equivalence | ||
| Energy Type (Technology) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Peak Wavelength (nm) | 414 nm ± 6 | 414 nm ± 6 |
| Dose rate (mW/cm²) | 22.4 | 22.4 |
| Dose (J/cm²) | 12 | 12 |
| Safety and Functionality | ||
| Electrical safety | Compliant (implied by K080591 clearance) | Compliant (IEC 60601-1: 2005) |
| Electromagnetic compatibility | Compliant (implied by K080591 clearance) | Compliant (IEC 60601-1-2: 2007) |
| Software verification/validation | Compliant (implied by K080591 clearance) | Compliant (IEC 62304: 2006) |
| Biocompatibility | Compliant (implied by K080591 clearance) | Compliant (IEC 10993) |
The document states, "In all instances, the Tanda Mini Skincare System functioned as intended," indicating that it met the acceptance criteria for these non-clinical tests. The core argument for substantial equivalence relies on the Tanda Mini having the same identical intended use and principle of operation and delivering energy at the same dose and dose rate as the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document details non-clinical engineering and safety tests rather than a clinical trial with a "test set" of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As no clinical study against a ground truth is reported for the Tanda Mini Skincare System, this is not applicable.
4. Adjudication Method for the Test Set
This information is not provided. Not applicable due to the lack of a reported clinical test set.
5. 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
An MRMC comparative effectiveness study was not performed. This device is a light-emitting diode therapy system for acne, not an AI-powered diagnostic or assistive tool, so this type of study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study as described (algorithm only without human-in-the-loop) was not performed. This device is a direct application therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests (electrical safety, EMC, software, biocompatibility), the ground truth is adherence to the specified international standards (e.g., IEC 60601-1, IEC 62304, IEC 10993). For the efficacy of treating acne, the device relies on the established efficacy of its predicate device with its identical treatment parameters. The predicate's efficacy would have presumably been established through clinical trials using outcomes data (e.g., lesion count reduction, global assessment scores) or expert consensus. This document, however, does not detail the specific ground truth strategy for the predicate.
8. The Sample Size for the Training Set
This information is not provided. The document describes a medical device, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided. Not applicable, as this is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the Tanda Mini Skincare System meets "acceptance criteria" is a series of non-clinical engineering and safety tests and a demonstration of substantial equivalence to a previously cleared predicate device (K080591).
- Study Design: The approach was to confirm that modifications (primarily ergonomic) to the device did not introduce new risks and that the device maintained the same fundamental technological characteristics and safety features as the predicate.
- Key Tests Conducted:
- Electrical safety (IEC 60601-1: 2005)
- Electromagnetic compatibility (IEC 60601-1-2: 2007)
- Software verification and validation (IEC 62304: 2006)
- Biocompatibility testing (IEC 10993)
- Outcome: "In all instances, the Tanda Mini Skincare System functioned as intended" for these tests, demonstrating compliance with the respective standards.
- Efficacy Argument: The efficacy for treating mild to moderate inflammatory acne is established by demonstrating that the Tanda Mini Skincare System has the same identical intended use, principle of operation, energy type, peak wavelength, dose rate, and dose as its predicate device, K080591, which was previously deemed safe and effective. The minor ergonomic differences were not considered to raise new questions of safety or effectiveness.
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510(k) SUMMARY
K124042
Syneron Beauty's Tanda Mini Skincare System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
.
Syneron Beauty Inc.
11-380 Jamieson Parkway Cambridge, Ontario, Canada N3C 4N4
Phone: +1-519-651-1177 X 225 Facsimile: +1-519-651-2277
Contact Person: Bobae Kim
Date Prepared: April 2, 2013
Name of Device and Name/Address of Sponsor
Tanda Mini Skincare System
Syneron Beauty Inc.
11-380 Jamieson Parkway Cambridge, Ontario, Canada N3C 4N4
Common or Usual Name
Light Emitting Diode Therapy System
Classification Name
Over-the-counter Powered Light Based Laser for Acne General and Plastic Surgery Devices Panel Regulation Number: 21 C.F.R 878.4810 Product Code: OLP
Predicate Device
Syneron Beauty Inc.'s Tanda Skincare System (K080591)
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Intended Use / Indications for Use
The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, blue light modules are indicated to treat mild to moderate inflammatory acne.
Technological Characteristics
The Tanda Mini Skincare System is a smaller version of its predicate device (K080951) that shares the same principal features and characteristics as the predicate. Both the devices are cordless, handheld units that have a single on/off push button that activates the units. The Tanda Mini Skincare System uses the same technology to deliver blue light at 414 nm to the treatment surface via light emitting diodes (LEDs) as its predicate. Furthermore, there have been no modifications to the safety features of its predicate, which includes a sensor for skin contact and temperature as well as sound indicators. The only changes made in the Tanda Mini Skincare System compared to the previously cleared predicate relates to additional ergonomic features such as a textured treatment surface, and a vibration indicator to signify the treatment is in progress. Furthermore, the total energy dose, dose rate, and treatment regimen remain the same as the previously cleared predicate device.
Performance Data
Risk analysis was performed to assess the modifications to the Tanda Mini Skincare System, and confirmed that no new risks are raised. The following non-clinical performance testing was conducted to re-validate the modified device, against the same test methods and criteria used on the predicate device cleared in K080591 that includes:
- Electrical safety (IEC 60601-1: 2005) .
- . Electromagnetic compatibility testing (IEC 60601-1-2: 2007)
- . Software verification and validation testing and (IEC 62304: 2006)
- Biocompatibility testing (IEC 10993) .
In all instances, the Tanda Mini Skincare System functioned as intended.
Substantial Equivalence
The Tanda Mini Skincare System is as safe and effective as the predicate device, the Tanda Skincare System (K080591). The Tanda Mini Skincare System has the same identical intended use and principle of operation as the predicate device. The main safety features that include the skin contact sensor and temperature sensor in the predicate device are also preserved in the Tanda Mini Skincare System. Furthermore, the Tanda Mini Skincare System delivers energy at the same dose and dose rate as the predicate device for the same indication and therefore no new questions of efficacy are raised in the modified device. The minor technical differences in modified ergonomics are directly
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correlated to its compact form and do not raise new issues of safety or effectiveness in the modified device compared to the predicate. Verification and validation through software testing, electrical safety and electromagnetic compatibility/interference testing demonstrated that the Tanda Mini Skincare System is as safe and effective as Tanda Skincare System. There were no new hazards identified as a result of these modifications and therefore the Tanda Mini Skincare System is substantially equivalent.
| Syneron Beauty Inc. | Syneron Beauty Inc(FormerlyLife Corp) | |
|---|---|---|
| Device Name | Tanda Mini SkincareSystem | Tanda Skincare System |
| 510(k) | K080591 | |
| IntendedUse/Indications forUse | Treatment of mild tomoderate inflammatoryacne. | Treatment of mild tomoderate inflammatoryacne. |
| Energy Type(Technology) | Light Emitting Diodes(LED) | Light Emitting Diodes(LED) |
| Peak Wavelength(nm) | 414 nm ± 6 | 414 nm ± 6 |
| Dose rate(mW/cm²) | 22.4 | 22.4 |
| Dose (J/cm²) | 12 | 12 |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 2, 2013
Syneron Beauty % Hogan Lovells US, LLP Ms. Janice Hogan Partner, Regulatory Counsel 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K124042
Trade/Device Name: Tanda Mini Skincare 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: OLP Dated: March 04, 2013 Received: March 04. 2013
Dear Ms. Hogan:
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. Iisting 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 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
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Page 2 - Ms. Janice Hogan
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Safety/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K124042
Device Name: Tanda Mini Skincare System
Indications for Use:
The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden
2013.04.02 09:16:00 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K124042
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§ 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.