SURESCAN

{0} K964831 # CLINICON CORPORATION CARLSBAD CALIFORNIA AUG - 8 1997 # 510(k) Summary Submitter: Clinicon Corporation 2260, Rutherford Road, Suite 101 Carlsbad, CA 92008 Phone Number: 619 930 0010 Fax Number: 619 930 0074 Contact Person: Alan Bunting Date Prepared: November 26th, 1996 Trade Name: SureScan Common Name: Laser Accessory Classification Name: Class II Substantial Equivalence Claimed To: 1. Hexascan - Lithan Techn. Inc. 510(k) # K 901008 2. CPG - Coherent Medical Inc 510(k) # not known 3. SureScan - Clinicon Corp. 510(k) # K 962242 # Description: SureScan adapts to laser systems with wavelengths in the visible spectrum from 430nm to 700nm (blue, green, yellow and red) and to lasers in the invisible spectrum from 755nm to 2940nm to deliver precise amounts of energy to tissue. SureScan comes equipped with multiple treatment patterns in multiple sizes. SureScan is programmable to enable adjustment of scan speed across tissue to ensure uniform laser absorption or ablation which significantly reduces thermal damage and thus the potential for post operative scarring. SureScan also has an adjustable spot overlap density and scanner dwell time feature which allows the surgeon to select individual treatment parameters most suitable for various tissue types and lesions. 2260 Rutherford Road, Carlsbad, CA 92008 • Tel: 619-930-0010 • Fax: 619-930-0074 000003 {1} Pattern outline and size are clearly displayed on tissue, allowing precise placement of the laser energy and alignment of subsequent scan shapes. ## Indications for Use: ### Wavelength range 430-1064 Nanometer In this wavelength range, SureScan is designed to assist in the partial or full coagulation or denaturation of a variety of benign epidermal vascular and pigmented lesions where precise dosimetry is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for applications in cutaneous laser surgery for the treatment of benign superficial vascular and pigmented lesions such as port wine stains angiomas, telangiectasia, café-au-lait marks, age spots, lentigines, tattoos and similar conditions. ### Wavelength range 1440-10640 Nanometer In this wavelength range, SureScan is designed to assist in a variety of procedures that require the ablation of soft tissue, where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for soft tissue ablation, such as scars, keloids, warts, skin malformations and similar conditions. ## Technical Description SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. SureScan juxtaposes laser beam spots with precisely controlled timing and predetermined amounts of space in between or with spatial overlap of these spots. Depending on the type of laser used and its wavelength, highly controlled tissue coagulation or ablation is achieved with minimal thermal injury. SureScan's operation is controlled via an existing laser foot switch, to eliminate any adjustment of the internal electronics or workings of the laser. To ensure precise transmission of the laser beam through the SureScan device and subsequent safe delivery of laser energy to tissue, a user controlled adjustment feature allows for realignment of the laser beam due to a misaligned fiber or other delivery system as it is directed through the SureScan hand piece. As a result, the operator is always assured of optimum beam quality without 'clipping', as the laser beam exits the SureScan hand piece. Different sized squares, rectangles, triangles, hexagons, parallelograms and lines may be selected and are outlined by the laser systems pilot laser. These various patterns are then automatically covered by the therapeutic laser and coagulate, denaturize or ablate tissue in a single scan cycle. This results in a more predictable and controlled tissue effect to optimize treatment results. 000004 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Fritz A. Brauer, Ph.D. President Clinicon Corporation 2260 Rutherford Road Carlsbad, California 92008 Re: K964831 Trade Name: SureScan Regulatory Class: II Product Code: GEX Dated: May 9, 1997 Received: May 12, 1997 AUG - 8 1997 Dear Dr. Brauer: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3} Page 2 - Fritz A. Brauer, Ph.D. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Enclosure {4} 510(k) Number (if known): K 964831 Device Name: SureScan Indications for Use: # CAUTION SureScan use is restricted for adaptation to laser systems that have received FDA clearance for cutaneous surgical applications and soft tissue ablation at the following specific wavelengths: 488nm, 511nm, 514nm, 520nm, 530nm, 532nm, 568nm, 577nm, 578nm, 585nm, 694nm, 752nm, 1064nm, 2940nm. Users should refer to the laser manufacturer's operating manual for applications that have been cleared for the specific wavelength. SureScan Wavelengths & Indications for Use (Consult Manufacturer's Manual for Cleared Applications) | 488nm | Blue/Green | CWArgon | Epidermal vascular lesions | | --- | --- | --- | --- | | 511nm | Green | Pulsed Copper Vapor | Epidermal vascular lesions | | 514nm | Green | CWArgon | Epidermal vascular lesions | | 520nm | Green | CWKrypton | Epidermal vascular lesions | | 530nm | Green | CWKrypton | Epidermal vascular & Pigm. Lesions | | 532nm | Green | CW/Pulsed KTP YAG | Epidermal vascular & Pigm. Lesions | | 568nm | Yellow | CWKrypton | Epidermal vascular & Pigm. Lesions | | 577nm | Yellow | CWDye | Epidermal vascular & Pigm. Lesions | | 578nm | Yellow | Pulsed Copper Vapor | Epidermal vascular & Pigm. Lesions | | 585nm | Yellow | CWDye | Epidermal vascular & Pigm. Lesions | | 694nm | Red | Pulsed Ruby | Epid. Pigm. Lesions & Tattoos | | 752nm | Red | Pu;lsed Alexandrite | Epid. Pigm. Lesions & Tattoos | | 1064nm | IR | Pulsed Nd:YAG | Epidermal Pigmented Lesions | | 2940nm | IR | CW Er:YAG | Soft Tissue Ablation | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)  Prescription Use ☑ (Per 21 CFR 801.109) OR Over-the-Counter Use 000006