The Tanda Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.

Device Description

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.

AI/ML Overview

The provided text describes the Tända Skincare System, its intended use, and a limited amount of information regarding safety data. However, it does not contain specific acceptance criteria for performance, nor does it detail a study that proves the device meets such criteria. The document focuses on regulatory approval (510(k) summary) and substantial equivalence to previously cleared devices.

Therefore, I cannot fully answer your request as the necessary information is not present in the provided text.

Based on the available text, here's what can be extracted and what is missing:

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

Acceptance Criteria: Not provided in the text.
Reported Device Performance: The text states, "A clinical Study... was undertaken and shown to demonstrate that the Tända Skincare System can be used safely as a nonprescription device." This is a general statement about safety, not performance criteria or specific performance metrics (e.g., reduction in acne lesions, percentage of responders). There are no quantitative measures of effectiveness mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not provided.
Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). It only mentions "A clinical Study under the supervision of a Health Care practitioner (MD)".

3. 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 provided. The text only mentions the study was "under the supervision of a Health Care practitioner (MD)."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided.

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 applicable. This device is a phototherapy system, not an AI-assisted diagnostic device. The study described focuses on the device's own safety as a standalone product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the device's performance as a standalone product, which is implied by the clinical safety study. However, specific performance metrics for "standalone" effectiveness are missing. The statement "can be used safely as a nonprescription device" focuses on safety, not efficacy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided. Given it's a treatment for acne, typical outcomes data (e.g., lesion count reduction, global assessment scores) would be relevant, but none are specified as "ground truth."

8. The sample size for the training set

Not applicable. This device does not appear to involve AI/machine learning models that require a "training set."

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the text '080541' in a handwritten style. The numbers are written in black ink on a white background. The text appears to be underlined.

NOV 1 4 2008

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted by:

Pharos Life Corporation 11-380 Jamieson Parkway Cambridge, Ontario N3C 4N4

1. Date Prepared: February 26, 2008

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 generaland plastic 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 intended as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

Substantial Equivalence: 5.

The Tända Skincare System is substantially equivalent to:

Tända Skincare System, Pharos Life Corp, K070185, (Aug 21, . 2007)
Zeno, Tyrell Inc., K043377, (July 13, 2005) .

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K080591

B. 2c. f.

6. Device Description:

7. Comparison of Technological Differences:

The intended use and technological characteristics of the Tända Skincare System are virtually identical to the combined intended uses and technological characteristics of the listed equivalent devices. Any differences between the Tända Skincare System and the equivalent devices have no significant influence on safety or effectiveness of the Tända product.

8. Additional Safety Data

A clinical Study under the supervision of a Health Care practitioner (MD) was undertaken and shown to demonstrate that the Tända Skincare System can be used safely as a nonprescription device.

The Tända Skincare System has undergone certification to IEC 60601-1. In addition, testing and analysis have demonstrated compliance to ISO 10993 (Biocompatibility).

The ocular hazard level presented by unprotected exposure to the Tända Skincare light source was defermine 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 indicate that the Tända Skincare System - does not pose a risk of retinal injury due to either the blue-light phototoxic effect, or the thermal damage mechanism. In addition, there are no negative additive effects from light exposure.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2008

Pharos Life Corporation % Mr. Phil Cuscuna 11-380 Jamieson Parkway Cambridge, Ontario, Canada N3C 4N4

Rc: K080591 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: November 12, 2008 Received: November 12, 2008

Dear Mr. Cascuna:

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 dcvices 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 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

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Page 2 - Mr. Phil Cuscuna

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 Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark M. Millerson

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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K080591

Indications for Use

10f1

510(k) Number:

Device Name: Tända Skincare System

Indications For Use:

The Tanda 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 (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)

Neilre for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K080591

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.