ND: YAG ACCESSORY FOR PHOTODERM SYSTEM

K980537 · Esc Medical Systems , Ltd. · GEX · Apr 15, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980537
• Device Name: ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
• Applicant: Esc Medical Systems , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Coagulation and hemostasis of vascular lesions and soft tissue.

Device Story

PhotoDerm® Nd:YAG Accessory is a handheld pulsed medical laser; operates at 1064 nm wavelength; replaces standard optical treatment head on existing PhotoDerm® systems. Device emits high-energy pulses (1-10 ms duration, up to 150 J/cm2) to target tissue. Used by clinicians for coagulation and hemostasis of vascular lesions and soft tissue. Energy delivery is comparable to predicate Nd:YAG laser systems. Benefits include controlled thermal coagulation for surgical applications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical specifications and performance standards comparison to predicate devices.

Technological Characteristics

Pulsed Nd:YAG laser; 1064 nm wavelength; 1-10 ms pulse duration; up to 150 J/cm2 energy output. Handheld accessory form factor. Conforms to 21 CFR 1040.10 and 1040.11. Operates as an accessory to the PhotoDerm® system.

Indications for Use

Indicated for coagulation and hemostasis of pigmented vascular lesions and soft tissue in patients requiring laser surgical intervention.

Regulatory Classification

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.

Predicate Devices

• Sharplan 3100 Nd:YAG Laser System
• Laserscope Orion Laser System

Submission Summary (Full Text)

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K 980537

510(K) PREMARKET NOTIFICATION

PhotoDerm® Nd:YAG Accessory ESC Medical Systems Ltd.

## 510(K) Summary

| Submitter: | ESC Medical Systems Ltd.<br>Yokneam Industrial Park<br>Yokneam,20692, Israel<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>Laserscope Orion Laser System |
| Device Description: | The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength<br>of 1064 nanometers. The device is operated by the PhotoDerm® system and<br>emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2.<br>The Nd: YAG laser accessory is a hand held device that replaces the standard<br>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<br>of the technical specifications, operating performance features, general physical<br>configuration and intended uses. The energy delivered to the tissue is in the<br>range of energy values delivered by the predicate devices. |
| Performance<br>Standards: | The PhotoDerm® Nd: YAG Accessory conforms with federal regulations and the<br>performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Conclusion: | The PhotoDerm® Nd: YAG Accessory is substantially equivalent to other<br>Nd: YAG laser systems in commercial distribution for similar applications |
| Additional<br>Information: | None requested at this time |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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