(233 days)
Not Found
No
The summary describes a standard diode laser system for treating vascular and pigmented lesions and does not mention any AI or ML components or capabilities.
Yes
The device is intended for the treatment of vascular and pigmented lesions, which means it is used to alleviate or cure a disease, injury, or medical condition.
No
The "Intended Use" states the device is "intended for the treatment of vascular and pigmented lesions," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "semiconductor diode laser system," which is a hardware component.
Based on the provided information, the ESC Diode Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of vascular and pigmented lesions. IVD devices are used for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system that operates at a specific wavelength. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for direct application to the patient's body for therapeutic purposes, which is the domain of medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.
Product codes
GEX
Device Description
The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 98 2119
510(K) PREMARKET NOTIFICATION
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Diode Laser System ESC Medical Systems Ltd.
4 1999
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FEB
510/K) Summary
| Submitter: | ESC Medical Systems Ltd.
Yokneam Industrial Park
Yokneam, 20692, Israel
Phone: 972-4-959-9000 Fax: 972-4-959-9050 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Zvi Ladin. VP, Clinical Applications and Regulatory Affairs |
| Date summary
prepared: | 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 System
StarLight™ Laser System
LaserLite Diode Surgical Laser System |
| Device Description: | The ESC Diode Laser System is a semiconductor diode laser system operating at
the 830nm wavelength |
| Intended Use: | The ESC Diode Laser System is intended for the treatment of vascular and
pigmented lesions including leg veins. |
| Comparison: | ESC Diode Laser System is comparable to its predicate devices in terms of the
technical specifications, operating performance features, general physical
configuration and intended uses. The energy delivered to the tissue is in the
range of energy values delivered by the predicate devices. |
| Performance
Standards: | The ESC Diode Laser System conforms with federal regulations and the
performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Conclusion: | The ESC Diode Laser System is substantially equivalent to other diode laser
systems in commercial distribution for similar applications |
| Additional
Information: | 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
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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.
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
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| 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