(233 days)
The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.
The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength
This 510(k) premarket notification for the ESC Diode Laser System does not contain the detailed information necessary to complete the requested table and study description. This document focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use, rather than presenting a performance study with acceptance criteria and results for the device itself.
Here's why the requested information cannot be fully provided from the given text:
- No specific acceptance criteria are defined or reported. The document states the device "conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems," but these are general safety and performance standards, not specific clinical or technical acceptance criteria with measurable metrics (e.g., specific treatment success rates, lesion clearance percentages, etc.) that would typically be found in a performance study.
- No performance study is detailed. The document does not describe any clinical or technical study conducted to evaluate the ESC Diode Laser System against specific performance metrics or acceptance criteria. It primarily focuses on comparing the device to existing predicate devices based on general characteristics.
- The document is a 510(k) summary and FDA letter, not a clinical study report. These types of documents aim to demonstrate equivalence for regulatory approval, not to present the results of a dedicated clinical trial or performance evaluation with all the requested details.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study design, sample sizes, expert involvement, adjudication, or ground truth establishment. These elements are not provided in the supplied 510(k) documentation.
{0}------------------------------------------------
K 98 2119
510(K) PREMARKET NOTIFICATION
. '
·
Diode Laser System ESC Medical Systems Ltd.
4 1999
. … ' ・・・・
FEB
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: | January 31, 1999 |
| Device Trade Name: | ESC Diode Laser System |
| Common name: | Diode Laser |
| Classification name: | Laser instrument, powered, surgical (class II medical device) |
| Equivalent Devices: | AOC Laser Care SystemStarLight™ Laser SystemLaserLite Diode Surgical Laser System |
| Device Description: | The ESC Diode Laser System is a semiconductor diode laser system operating atthe 830nm wavelength |
| Intended Use: | The ESC Diode Laser System is intended for the treatment of vascular andpigmented lesions including leg veins. |
| Comparison: | ESC Diode Laser System is comparable to its predicate devices in terms of thetechnical specifications, operating performance features, general physicalconfiguration and intended uses. The energy delivered to the tissue is in therange of energy values delivered by the predicate devices. |
| PerformanceStandards: | The ESC Diode Laser System conforms with federal regulations and theperformance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Conclusion: | The ESC Diode Laser System is substantially equivalent to other diode lasersystems in commercial distribution for similar applications |
| AdditionalInformation: | None requested at this time |
{1}------------------------------------------------
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1339 FEB
Dr. Zvi Ladin Vice President Clinical Applications and Regulatory Affairs ESC Medical Systems Ltd. Yokneam Industrial Park P.O. Box 240 Yokneam 20692, Israel
K982119 Re: Trade Name: Diode Laser Regulatory Class: II Product Code: GEX Dated: November 3, 1998 Received: November 6, 1998
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 requirement, as set forth in the Quality System Regulation (OS) 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
{2}------------------------------------------------
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.
Stupt Rhodes
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
{3}------------------------------------------------
| 510(k) Number (if known): | K982119 |
|---|---|
| Device Name: | ESC Diode Laser System |
Indications For Use:
The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Purdus
(Division Sign-Off) Division of General Restorative Devices K982119 510(k) Number _
Prescription Use X (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.