← Product Code [ILY](/productcode/ILY) · K081505 # THERAGEM PROFESSIONAL T1002 (K081505) _Medica Health, Ltd. · ILY · Nov 19, 2008 · Physical Medicine · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K081505 ## Device Facts - **Applicant:** Medica Health, Ltd. - **Product Code:** [ILY](/productcode/ILY.md) - **Decision Date:** Nov 19, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5500 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a color therapy mineral lamp that helps to temporarily increase local blood circulation where applied, and temporarily relieve minor muscle, joint aches and pains through the use of light and color applied in a non-contact, non-heat manner. This color therapy Light device is designed for use at home, spa facilities and therapeutic centers. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 provides interchangeable multi colored heads to the color therapy lamp in which there is no hazard for contacting the low ambient temperature colored heads. The color therapy multi-101 ved heads are secured within the lamp housing and utilizes an ergonomic stand which is designed for adjustable positioning by users in a domestic and/or professional environment. An adjustable timer control for safety functions is also incorporated into the THERAGEM PROFESSIONAL T1002. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 allows the user control of the timer and intensity function thus assuming the safety level of device. ## Device Story Theragem Professional T1002 is a color therapy mineral lamp; utilizes light and color to provide non-contact, non-heat therapy. Device features interchangeable colored heads and an ergonomic stand for adjustable positioning. Operated by users in home, spa, or therapeutic center settings. Includes adjustable timer and intensity controls for user-managed safety. Principle of operation involves application of light to target areas to increase local blood circulation and relieve minor aches/pains. Healthcare providers or patients use the device to deliver adjunctive therapy; output is visual light/color application. Benefits include temporary pain relief and improved local circulation. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Color therapy mineral lamp; non-heating, non-contact light application. Features interchangeable colored heads, ergonomic adjustable stand, and integrated timer/intensity control. Operates as a standalone unit for domestic or professional use. ## Regulatory Identification An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating. ## Special Controls *Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. ## 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}------------------------------------------------ (081505 NOV 1 9 2008 ### 510(K) Summary Preparation: May 8th, 2008 Manufacturer's Contact Person: Terri Cmorey Tel (954) 725-6493 Fax (954) 415-6059 Medica Health LTD 2842 Kelly Brooke Lane Deerfield Beach, Florida 33442 ## Trade Name: Theragem Professional T1002 # Classification Name, Classification Number, Class, Classification Reference: | Class. Name | Class. No | Class | 21CFR | |----------------------------|-----------|-------|----------| | Color Therapy Mineral Lamp | ILY | II | 890.5500 | Regulation Name: Lamp, non-heating, for adjunctive use in pain therapy There are no regulatory standards or special controls applicable for Special Controls: this device. The Medica Health LTD, THERAGEM PROFESSIONAL Indications For Use: T1002 is a color therapy mineral lamp that helps to temporarily increase local blood circulation where applied, and temporarily relieve minor muscle, joint aches and pains through the use of light and color applied in a non-contact, non-heat manner. This color therapy Light device is designed for use at home, spa facilities and therapeutic centers. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 provides interchangeable multi colored heads to the color therapy lamp in which there is no hazard for contacting the low ambient temperature colored heads. The color therapy multi-101 ved heads are secured within the lamp housing and utilizes an ergonomic stand which is designed for adjustable positioning by users in a domestic and/or professional environment. An adjustable timer control for safety functions is also incorporated into the THERAGEM PROFESSIONAL T1002. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 allows the user control of the timer and intensity function thus assuming the safety level of device. ### Contraindications: None {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medica Health, Ltd. % Terri Cmorey 2842 Kelly Brook Lane Deerfield Beach, Florida 33442 NOV 1 9 2008 Re: K081505 Trade/Device Name: Theragem T1002 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 7, 2008 Received: November 10, 2008 Dear Terri Cmorey: 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 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. {2}------------------------------------------------ #### Page 2 - Terri Cmorey 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 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 Presmarket, 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. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(K) Number (if known): K081505 Devise Name: Theragem T1002 Indications For Use: The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a lamp indicated for adjunctive use and providing temporary relief of minor muscle and joint pain. This device helps to temporarily increase local blood circulation where applied. Concurrence of CDHR of Device Evaluation (ODE) (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Division of General, Restorative And Neurological Devices 510(k) Number Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-the-Counter Use (Optional Format 1-2-96) Nelon Ogle formen (Division Sign-Off) (Division Sign of General, Restorative, Division rological Devices 510(k) Number K081505 --- **Source:** [https://fda-staging.innolitics.com/device/K081505](https://fda-staging.innolitics.com/device/K081505) **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. 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