(63 days)
Not Found
Not Found
No
The summary describes a pulsed laser accessory with specific physical parameters (wavelength, pulse duration, energy density) and its intended use for coagulation and hemostasis. There is no mention of any computational or algorithmic processing, let alone AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for "coagulation and hemostasis of vascular lesions and soft tissue," which are therapeutic applications.
No
Explanation: The device is described as being for "coagulation and hemostasis of vascular lesions and soft tissue," which indicates a therapeutic rather than a diagnostic purpose. It treats conditions rather than identifying or analyzing them.
No
The device description clearly states it is a "hand held device" and a "pulsed medical laser operating at a wavelength of 1064 nanometers," indicating it is a hardware accessory, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation and hemostasis of vascular lesions and soft tissue." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details a laser system used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, the PhotoDerm® Nd: YAG accessory is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 980537
510(K) PREMARKET NOTIFICATION
PhotoDerm® Nd:YAG Accessory ESC Medical Systems Ltd.
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 | February 5, 1998 |
| prepared: | |
| Device Trade Name: | PhotoDerm® Nd: YAG Accessory |
| Common name: | Nd: YAG Laser |
| Classification name: | Laser instrument, powered, surgical (class II medical device) |
| Equivalent Devices: | Sharplan 3100 Nd:YAG Laser System
Laserscope Orion Laser System |
| Device Description: | The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength
of 1064 nanometers. The device is operated by the PhotoDerm® system and
emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2.
The Nd: YAG laser accessory is a hand held device that replaces the standard
optical treatment head used in the PhotoDerm® machines. |
| Intended Use: | Coagulation and hemostasis of pigmented vascular lesion and soft tissue |
| Comparison: | PhotoDerm® Nd:YAG Accessory 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 PhotoDerm® Nd: YAG Accessory conforms with federal regulations and the
performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Conclusion: | The PhotoDerm® Nd: YAG Accessory is substantially equivalent to other
Nd: YAG laser systems in commercial distribution for similar applications |
| Additional
Information: | None requested at this time |
1
Image /page/1/Picture/10 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1998
Dr. Zvi Ladin ·Vice President Clinical Applications and Requlatory Affairs ESC Medical Systems Limited Yokneam Industrial Park P.O. Box 240 Yokneam, Israel 20692
Re: K980537 Trade Name: PhotoDerm® Nd:YAG Accessory Regulatory Class: II Product Code: GEX Dated: February 5, 1998 Received: February 11, 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 (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 requlation may result in requlatory 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 requlations.
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Page 2 - Dr. 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,
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):
Nd:YAG accessory for PhotoDerm® Device Name:
Indications For Use:
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stuptin Alwdia
tive Devices K980537
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use