(144 days)
The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.
DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area
The provided text is a 510(k) Premarket Notification for the DermaScan™ Surgical Laser Scanner. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it's a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on device description, intended use, and comparison to existing products. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no performance studies were conducted or submitted for this device.
Therefore, I cannot provide the requested information from this document. The sections on acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC studies are not present.
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510(K) PREMARKET NOTIFICATION
Karanaka
DermaScan™ Surgical Laser Scanner ESC Medical Systems Ltd.
OCT 2 4 1997
510(K) Summary
| Submitter: | ESC Medical Systems Ltd.Yokneam Industrial ParkYokneam,20692, IsraelPhone: 972-4-959-9000 Fax: 972-4-959-9050 |
|---|---|
| Contact: | Dr. Zvi Ladin, VP, Clinical Applications and Regulatory Affairs |
| Date summaryprepared: | May 29, 1997 |
| Device Trade Name: | DermaScan™ Surgical Laser Scanner |
| Common name: | Laser Accessory |
| Classification name: | Class II |
| Equivalent Devices: | Sahar Technologies SofTouch Laser Accessory, 510(k) #K964684Clinicon Surescan Laser Scanner, 510(k) #K962242 |
| Device Description: | DermaScan™ Surgical Laser Scanner is a microprocessor controlled device thatconverts a surgical laser device into an advanced aesthetic surgery tool for avariety of cosmetic procedures. The device uses motorized mirrors to deflect alaser beam over a specified area in a uniform and controlled manner. Using asophisticated interface the user can specify a large number of parameters toachieve a scanning procedure that is tailored to the individual needs of thepatient. The scanner then controls the actual tissue ablation process to achieve auniform removal of tissue over the entire area. An aiming beam is used tooutline the treated area |
| Intended Use: | Ablation of soft tissue |
| Comparison: | DermaScan™ uses the same basic technology as the predicate devices. It offersadded versatility to the scan parameters that are offered by the predicate devices.It also offers a larger and more versatile display that improves the humaninterface, and adds new safety features. |
| NonclinicalPerformance Data: | None |
| Clinical PerformanceData: | None |
| Conclusion: | The DermaScan™ Surgical Laser Scanner is substantially equivalent to otherlaser scanners in commercial distribution for the same surgical application |
| Additional Information | None requested at this time |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 2 4 1997
Dr. Zvi Ladin · Vice President, Clinical Applications and Regulatory Affairs ESC Medical Systems. Ltd. Yokneam Industrial Park, PO Box 240 Yokneam 20692, Israel
Re: K972028 Trade Name: DermaScan™ Surgical Laser Scanner Regulatory Class: II Product Code: GEX Dated: September 3, 1997 Received: September 12, 1997
Dear Dr. Ladin:
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.
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Page 2 - Dr. Zvi Ladin
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,
S. Gail M. Witter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K972028
DermaScan™ Surgical Laser Scanner ි avice Name:
indications For Use:
The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number __ C172028
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.