LUMAPROBE

{0}------------------------------------------------ K073600 OCT 01 2008 ## FDA 510K Summary of Safety and Effectiveness for LumaProbe - 1. General Information | Submitter: | Clareblend Inc.<br>3555 Airway Dr.<br>Suite 307<br>Reno, Nevada 89511<br>800-334-7126<br>775-332-3852 Fax | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | C/O Jill Creasy<br>Aesthetica-Tech<br>675 Pine Street<br>Elgin, IL 60123<br>847-429-9631<br>847-429-9633 Fax<br>contact@aestheticatech.com | | Summary Preparation Date: | October 22, 2007 | | Names | | | Device Name: | LumaProbe Model # 7002-01 with hand probes (Models: 7201-415,<br>7204-631, and 7205-830 | | Classification Name: | Laser instrument, surgical, powered device; GEX, ILY<br>FDA Class II category <p>Although this device is not a laser, the specifications developer feels this is the closest applicable classification name.</p> | #### 3. Predicate Device 2. LumaProbe is substantially equivalent to the Omnilux Blue (K030883), Omnilux Revive (K030426), Omnilux Plus (K043317) #### 4. Device Description The LumaProbe is a device that utilizes Light Emitting Diodes to provide LED light to the body. The LumaProbe Red, IR and Blue are a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- nm and Blue is 415 +/- 5nm. The LumaProbe unit contains the power supplies and the control unit; it has the capabilities to power and sequence up to 2 attachable probes depending on the product model, that deliver the light to the skin as they are moved over the skin surface. The STOP button directly on the probes allows the user to immediately remove all power to the probes. #### 5. Indications for Use: LumaProbe (Red-631) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions LumaProbe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris. LumaProbe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. {1}------------------------------------------------ # Ko 73000 #### Comparison of Technological Differences: 6. The intended use and technological characteristics of the LumaProbe system are virtually identical to the intended use and technological characteristics of the listed equivalent devices. Any differences between the LumaProbe and the equivalent devices have no significant influence on safety or effectiveness of the LumaProbe product. #### 7. Conclusions Based upon an analysis of the overall performance characteristics for the LumaProbe, Clareblend, Inc. believes that no significant differences exist between this system and the predicate systems quoted, therefore, the LumaProbe Light Therapy device does not impose any new safety or effectiveness concerns. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 0 1 2008 Clareblend, Inc. % Aesthetica-Tech Ms. Jill Creasy Medical Device Consultant 675 Pine Street Elgin, Illinois 60123 Re: K073000 Trade/Device Name: LumaProbe Model # 7002-01 with hand probes (Models: 7201-415, 7204-631, and 7205-830) 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, ILY Dated: September 15, 2008 Received: September 18, 2008 Dear Ms. Creasy: 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 {3}------------------------------------------------ Page 2 - Ms. Jill Creasy forth in the quality systems (OS) 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 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 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 Wilkerson 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 (if known): K_073000 Device Name: LumaProbe Model # 7002-01 with hand probes (Models: 7201-415, 7204-631, and 7205-830 ## Indications for Use: The LumaProbe is intended to provide light to the body. - LumaProbe (Red-631) is generally indicated for the treatment of superficial, benign vascular, and pigmented A. lesions - LumaProbe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially в. indicated for the treatment of mild to moderate inflammatory acne vulgaris. - LumaProbe (R-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis C. and muscle spasm, relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. Prescription Use X AND/OR (21 CFR Part 801 Subpart D) Over-The-Counter Use (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *Milke* (Division Sign-Off) Division of General, Restorative, and Neurological Devices K073000 510(k) Number Page 1 of 1 -