MOBILE VERSA LIGHT

{0}------------------------------------------------ ## 510(k) Summar #### K111049 Submission Date: April 10, 2011 ## 1. Submitter Information: AEGIS Regulatory, Inc. - Robert, T. Wagner 1131 Anthem View Lane Knoxville, TN 37922 Tel.: 865-982-5552 Email: bob@fdalistingconsultants.com For Manufacturer: MedTek Lighting, Inc. Attn: Mr. Gary Richardson 3 Depot St. Hudson Falls, NY 12839 Tel.: 518-747-3310 #### 2. General Information: - Classification Name: FTC Ultraviolet lamp for dermatologic disorders 2.1 - Common/Usual Name: UV Biotek Mobile- Lite and Versa- Lite 2.2 - 2.3 Proprietary Names: UV Biotek Mobile-Lite model 600 and Versa-Lite model 1400 - 2.4 Classification: Class II - 2.5 Classification Number: 878.4630 - 2.6 Product Code: FTC #### 3. Device Description: The UV Biotek Mobile-Lite model 600 is a lightweight metal box containing six Philips 15-Watt TL-01 nUVB (narrowband UVB) lamps, configured as a suitcase for portability, designed to be placed either on a table or a stand for easy exposure to feet, lower legs, hands and lower arms. A remote control timer module is used to program exposure times and dosages. The UV Biotek Versa-Lite model 1400 is a phototherapy device, freestanding support with 3 lighting panels containing a total of 14 Philips TL20W/01 (narrowband UVB) lamps. The panels can be used simultaneously or individually, depending on treatment needed. System dimensions: 83" high, 27" deep, and 28" wide - when system panels are in start position. {1}------------------------------------------------ #### 4. Intended Use: - The UV Biotek Mobile-Lite model 600 is for individuals who require L specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI) - The UV Biotek Versa-Lite model 1400 is for individuals who require 트 specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI) #### 5. Substantial Equivalence to Predicate Device(s): These devices are substantially equivalent to the following predicate devices, which are currently in safe and effective commerce: - 1. K050695 Flex Controlled Phototherapy (Daavlin) - 2. K872649 Hand/Foot UVA/UVB (National Biological) - 3. K933952 Phototherapeutix 800 (Avex, now Medtek Lighting) - 4. K031800 Solrx 500 Series (Solarc) - 5. K904427 Panosol II UVB- 206 (National Biological) Please see attached Predicate Comparison Chart for detailed information. {2}------------------------------------------------ Predicate Comparison Char | Device | Company | K" Number | Indications for Use | Power | Treatment Spot Size | Dimensions of Device | Housing Materials and Construction | Energy Source | Treatment Regime | Target Population | Number of Lamps | Model Number | Wattage | Output UVB (W) | Lamp Voltage | Lamp Current | Length of Lamp | Light Source | Wavelength Range | Product Codes | |----------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------|------------------------------------------------|------------------------------------------------|-------------------------|--------------------------------------|-------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------|---------|--------------------------|--------------------------|--------------|--------------------------|--------------------------|--------------------------------------------------------------------|---------------| | FLEX CONTROLLED PHOTOTHERA Hand/Foot UVA/UVB | Daavlin Distributing Company | K050695 | For the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI) | 120v 60 hz | Hand and Foot | 27.5" x 35" (HW) panels fully open | Steele safety shield, UV lamps, timer, googles | 12v Power Adapter | Prescribed by physician | People diagnosed with psoriasis, vitiligo, and eczema | 8 | Narrowband UVB Lamps<br>TL 20W/01RS | 20w | 2.3 | 57 | 0.37 | 24" | Fluorescent Ultra Violet | 311 nm (Narrow Band UVB), 305 nm (Broad Band UVB) and 350 nm (UVA) | FTC | | National Biological | K872649 | For individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders. | 120v 60 hz | Hand and Foot<br>3-4 Square feet | 24"W x 12 ¾"H x 20 "D | Steele safety shield, UV lamps, timer, googles | 12v Power Adapter | Prescribed by physician | People diagnosed with skin disorders | 8 | Narrowband UVB Lamps<br>Philips TL-01<br>20/40/100 | 2.3/4.6/17.7<br>57/104/126<br>.37/.43/.97 | 24" | Fluorescent Ultra Violet | 311 nm (Narrow Band UVB) | FTC | | | | | | Solrx 500 Series | Solarc | K031800 | For individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders. | 120v 60 hz | Spot, Hand, and Foot<br>2 square feet | 15" x 27.5" (HW) | Steele safety shield, UV lamps, timer, googles | 12v Power Adapter | Prescribed by physician | People diagnosed with'skin disorders | 5 | Narrowband UVB Lamps<br>PL-L36W/01<br>Lamp Wattage 36w | 6.2 | 106 | 0.43 | 24" | Fluorescent Ultra Violet | 311 nm (Narrow Band UVB) | FTC | | ア。ナ KIIloy 9 1 · : ・ . 3.0+ 3 of 5 . {3}------------------------------------------------ | Page 1<br>Phototherapeutix 800<br>Avex, now Medtek Lighting | MedTek UV Biotek Versa Lite<br>Medtek Lighting | MedTek UV Biotek Mobile Lite<br>Medtek Lighting | Panosol II UVB-206<br>National Biological | |-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | K993952 | K | K | K904427 | | For individuals who require<br>specific Ultraviolet radiation<br>therapy for diagnosed skin<br>disorders. | For the treatment of psoriasis,<br>vitiligo, and atopic dermatitis<br>(eczema) on all skin types (I - VI) | For the treatment of psoriasis,<br>vitiligo, and atopic dermatitis<br>(eczema) on all skin<br>types (I - VI) | For the treatment of psoriasis,<br>vitiligo, and atopic dermatitis<br>(eczema) on all skin<br>types (I - VI) | | 120v 60 hz<br>Full Body | 120v 60 hz<br>Spot, Hand, and Foot<br>2-3 feet | 120v 60 hz<br>Spot, Hand, and Foot<br>2-3 feet | 120v 60 hz<br>Spot, Hand, and Foot<br>2-3 feet | | 3" x 38" x 83" (HWD) | 27.5" x 35" (HW) panels fully open | Open- 18" x 34 1/2" x .17 1/2"<br>(HWD) | 29-1/2"W x 25-1/2"H x 4-12"D<br>(11-1/2"D with stand) | | Steele safety shield, UV lamps,<br>timer, googles | Steele safety shield, UV lamps, timer,<br>googles, stand & wheels | Steele safety shield, UV lamps,<br>timer, googles | Steele safety shield, UV lamps, timer,<br>googles, stand & wheels | | 12v Power Adapter | 12v Power Adapter | 12v Power Adapter | 12v Power Adapter | | Prescribed by physician | Prescribed by physician | Prescribed by physician | Prescribed by physician | | People diagnosed with skin<br>disorders | People diagnosed with psoriasis,<br>vitiligo, and eczema | People diagnosed with psoriasis,<br>vitiligo, and eczema | People diagnosed with psoriasis,<br>vitiligo, and eczema | | 3 Narrowband UVB Lamps<br>Philips TL20W/01<br>Lamp Wattage 20w | 6 NarrowBand UVB Lamps<br>Philips TL101<br>Lamp Wattage 15w | 14 NarrowBand UVB Lamps<br>Philips TL20W/01<br>Lamp Wattage 20w | 8 Narrow Band UVB Lamps<br>Philips TL20W/01<br>Lamp Wattage 20w | | 2.3<br>57<br>0.37 | 2.3<br>48<br>0.23<br>24" | 2.3<br>57<br>0.37<br>24" | 2.3<br>57<br>0.37<br>24" | | Fluorescent Ultra Violet<br>311 nm (Narrow Band UVB) | Fluorescent Ultra Violet<br>311 nm (Narrow Band UVB) | Fluorescent Ultra Violet<br>311 nm (Narrow Band UVB) | Fluorescent Ultra Violet<br>311 nm (Narrow Band UVB) | | ETC | ETC | ETC | ETC | ・・ |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 4 of 5 ୍ତ ። {4}------------------------------------------------ K. 111049 8-5 of 5 #### 6. Substantial Equivalence Discussion: These devices have the same technological characteristics as the cited predicate devices. Both devices use the same design, material, and energy source as the cited predicates. After an analysis of the safety, indications, intended uses, performance features, design materials, chemical composition, energy source, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicates listed in section 5 of this summary. Therefore substantial equivalency is requested. #### 7. Performance Standards: These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are found to be in compliance with EN/IEC 60601-1-1 and EN/IEC 60601-1-2. #### 8. Biocompatibility: The patient contact material on the Mobile Lite and Versa Lite is Acrylic and is the same material used in the cited predicate devices. The biocompatibility of this material is well known and accepted. #### 9. Sterilization / Use: The Mobile Lite and Versa Lite is a non-sterile device, and therefore this section is not applicable. Cleaning Instructions are listed in the User's Manual. #### Conclusion After an analysis of the safety, indications, intended uses, performance features, design materials, chemical composition, energy source, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicates listed in section 5 of this summary. Therefore substantial equivalency is requested. {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAY 2 5 2012 Medtek Lighting Corporation % Aegis Regulatory, Incoporated Mr. Robert Wagner CEO 1131 Anthem View Lane Knoxville, Tennessee 37922 Re: K111049 Trade/Device Name: UV Biotek-Mobile-Lite model 600 and Versa-Lite model 1400 Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: May 14, 2012 Received: May 21, 2012 Dear Mr. Robert Wagner: 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. 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. {6}------------------------------------------------ ## Page 2 - Mr. Wagner 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 device-related adverse events) (21 CFR 803); 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. 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/Resourcesfor You/Industrv/default.htm. Sincerely yours, Euid Keith Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ 上111049 p. 1 o.t 1 # Indications for Use 510(k) Number (if known): Device Names: UV Biotek- Mobile-Lite model 600 and Versa-Lite model 1400 Indications For Use - Part 878.4630: The UV Biotek Mobile-Lite model 600 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI) The UV Biotek Versa-Lite model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI) Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nek RP Osl (Division Sign Off) Sormkn (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices Page 1 of ﺗ 510(k) Number K111049