← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K070185 # TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 (K070185) _Pharos Life Corporation · GEX · Aug 21, 2007 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070185 ## Device Facts - **Applicant:** Pharos Life Corporation - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Aug 21, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne. ## Device Story Modular platform using light treatment heads with onboard electronic controls; delivers solid-state light source treatments for mild to moderate inflammatory acne. Device operates via light emission; intended for dermatological application. Safety profile includes IEC 60601-1 certification, ISO 10993 biocompatibility, and IEC 60825-1 laser safety compliance. Ocular hazard assessment confirms no risk of retinal injury from blue-light phototoxic effects or thermal damage. Device provides phototherapeutic light to treat acne conditions. ## Clinical Evidence Bench testing only. Compliance demonstrated with IEC 60601-1 (electrical safety), ISO 10993 (biocompatibility), and IEC 60825-1 (laser safety). Ocular hazard analysis performed using ACGIH and ICNIRP standards confirmed no risk of retinal injury. ## Technological Characteristics Modular platform with light treatment heads; solid-state light source. Complies with IEC 60601-1, ISO 10993, and IEC 60825-1. Accessible Emission Limit (AEL) below Class I threshold. ## Regulatory 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. ## Predicate Devices - BLU-U, MODEL 4170, DUSA PHARMACEUTICALS, INC ([K031805](/device/K031805.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 and
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 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) {1}------------------------------------------------ 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. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with three lines above them. 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 {3}------------------------------------------------ # 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 {4}------------------------------------------------ # 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070185](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070185) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com