(214 days)
The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
The provided 510(k) summary (K070185) for the Tända Skincare System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This document primarily focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) and detailing safety certifications.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred/stated based on the provided document:
1. Table of acceptance criteria and the reported device performance
The 510(k) summary does not mention specific quantitative acceptance criteria for treating acne or report detailed device performance metrics in relation to such criteria. The document states the device's intended use is "to treat Acne" and indicates that "Blue light modules are indicated to treat mild to moderate inflammatory acne."
2. Sample sized used for the test set and the data provenance
Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.
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
Not mentioned in the document. This device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a light therapy device, not an algorithm. Performance assessment typically involves clinical studies on patients, which are not described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not mentioned in the document. For a physical therapy device like this, ground truth would typically refer to clinical improvement or clearance of acne based on dermatologist assessment or objective metrics.
8. The sample size for the training set
Not applicable/mentioned. This is a physical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable/mentioned.
Summary of what is present in the document regarding "proof" of meeting criteria:
The document focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) based on "virtually identical" intended use and technological characteristics. It also states that "Any differences... have no significant influence on safety or effectiveness."
Additionally, it provides safety data demonstrating compliance with:
- IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- ISO 10993 (Biocompatibility)
- IEC 60825-1 (Laser Safety), with an Accessible Emission Limit (AEL) below the Class I threshold.
- Evaluation of ocular hazard levels, concluding no risk of retinal injury from blue-light phototoxic effect, thermal damage, or additive effects.
These safety certifications and comparisons to the predicate device form the basis for the FDA's 510(k) clearance, indicating that the device is deemed as safe and effective as the legally marketed predicate. However, it does not detail specific clinical performance criteria or a study that quantitatively measures the device's efficacy against those criteria.
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Ko70185
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted by: Pharos Life Corporation 11-380 Jamieson Parkway Cambridge, Ontario N3C 4N4
1. Date Prepared:
July 30, 2007
2. Contact Person:
Phil Cuscuna Tel.: 519 651-1177, ext 225 Fax: 519 651-2277 Email: phil.cuscuna@pharoslife.com
3. Device Name and Classification:
| Trade Name: | Tända Skincare System |
|---|---|
| Common Name: | Tända Skincare System |
| Classification Name: | Laser surgical instrument for use in general andplastic surgery and in dermatology |
| Classification Panel: | General & Plastic Surgery |
| CFR Section: | 21 CFR §878.4810 |
| Device Class: | Class II |
| Device Code: | GEX |
4. Intended Use:
The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
5. Substantial Equivalence:
The Tända Skincare System is substantially similar to:
BLU-U, MODEL 4170, DUSA PHARMACEUTICALS, INC K031805 (Sep 9, 2003)
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K0701PT
Device Description: 6.
The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
7. Comparison of Technological Differences:
The intended use and technological characteristics of the Tända Skincare System are virtually identical to the intended use and technological characteristics of the listed equivalent device. Any differences between the Tända Skincare System and the equivalent device have no significant influence on safety or effectiveness of the Tända product.
8. Additional Safety Data:
The Tända Skincare System has undergone certification to IEC 60601-1. In addition, testing and analysis have demonstrated compliance to: ISO 10993 (Biocompatibility) and IEC 60825-1 (Laser Safety). The later demonstrated an Accessible Emission Limit (AEL) below the AEL Class I threshold.
The ocular hazard level presented by unprotected exposure to the Tända Skincare light source was determine by applying the calculations specified in Threshold Limit Values for Chemical Substances and Physical Agents & Biological Exposure Indices of the American Conference of Governmental Industrial Hygienists Worldwide and the standards of the International Commission on Non-ionizing Radiation Protection. The results indicated that the Tända Skincare System - did not pose a risk of retinal injury due to either the blue-light phototoxic effect, or the thermal damage mechanism. In addition, there were no additive effects from light exposure.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pharos Life Corporation % Mr. Phil Cuscuna Quality & Regulatory Affairs Manager 11-380 Jamieson Parkway Cambridge, Ontario Canada, N3C 4N4
AUG 2 1 2007
Re: K070185
Trade/Device Name: Tända 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: GEX Dated: July 30, 2007 Received: July 31, 2007
Dear Mr. Cuscuna:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Phil Cuscuna
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
thichard D. Cappe
FOR
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K070185
Device Name: Tända Skincare System
Indications For Use:
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
thutary P. Cooper
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Overological Devices
510(k) Number K070185
§ 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.