PHOTODERM HR SYSTEM

K974536 · Esc Medical Systems , Ltd. · GEX · May 20, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974536
• Device Name: PHOTODERM HR SYSTEM
• Applicant: Esc Medical Systems , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PhotoDerm® HR is used for the removal of unwanted hair.

Device Story

PhotoDerm® HR is an electro-optic medical device for photothermal removal of unwanted hair. Device utilizes light energy to target hair follicles; principle of operation involves photothermal interaction to achieve hair removal. Operated by clinical professionals in a medical setting. Output consists of controlled light pulses applied to the skin surface. Clinical benefit is the effective removal of unwanted hair. Healthcare providers use the device to perform hair removal procedures based on clinical assessment of patient needs.

Clinical Evidence

Multi-center clinical study conducted to evaluate hair clearance rates and adverse effects. Data compared against published clinical performance metrics of predicate devices. Study results support safety and effectiveness claims.

Technological Characteristics

Electro-optic medical device; utilizes light energy for photothermal treatment. Form factor is a clinical system. No specific materials or software algorithm details provided in the source document.

Indications for Use

Indicated for the removal of unwanted hair in patients seeking hair removal treatment.

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

• EpiLight™ Hair Removal System (K963249)
• LT-100 ND: YAG Laser Hair Removal System (K950019)
• SLS Chromos 694 QD Ruby Laser (K962109)
• Epilaser Normal Mode Ruby Laser (K963947)
• Sharplan Ruby Laser System (K962446)

Submission Summary (Full Text)

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MAY 2 0 1998

K 974536

# 510(K) SUMMARY- SUMMARY OF SAFETY AND I. EFFECTIVENESS

ESC Medical Systems, Ltd Submitter's name:

Yokneam Industrial Park Submitter's address: PO Box 240 Yokneam 20692 ISRAEL

011-972-4-959-9000 Telephone:

001-972-4-959-9050 Fax:

PhotoDerm® HR Name of device:

#### Predicate devices:

- 1. EpiLight™ Hair Removal System made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249
- 2. LT-100 ND: YAG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510(k) #K950019.
- 3. SLS Chromos 694 QD Ruby Laser made by Classy Lady by MEHL of Gainesville, Florida. 510(k) #K962109.
- 4. Epilaser Normal Mode Ruby Laser made by Spectrum Medical Technologies of Lexington, Massachusetts. 510(k) #K963947.
- 5. Sharplan Ruby Laser System made by Sharplan Lasers, Inc of Allendale, New Jersey. 510(k) #K962446.

### Description of device:

PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.

#### Summary:

Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the PhotoDerm® HR can be based.

#### Intended use:

The PhotoDerm® HR is intended for the removal of unwanted hair.

ESC Proprietary Information I. 1-1

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## Comparing technical characteristics:

Both a technical comparison and clinical trials were performed by ESC Medical Systems to establish the substantial equivalence to the predicate devices.

ESC Medical Systems has also conducted a multi-center clinical study in which unwanted hair was treated by the PhotoDerm® HR . This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the PhotoDerm® HR were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices. It is ESC's opinion that this comparison demonstrates that the PhotoDerm® HR is as safe and as effective as the predicate devices in the removal of unwanted hair.

No performance standards applicable to the PhotoDerm® HR have been adopted under Section 514 of the Act.

In summary we believe that the analysis and clinical data establish that the PhotoDerm® HR is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Dr. Zvi Ladin ·Vice President Clinical Applications and Regulatory Affairs ESC Medical Systems, Limited Yokneam Industrial Park P.O. Box 240 Yokneam, 20692 Israel

Re : K974536 PhotoDerm HR System Trade Name: Regulatory Class: II Product Code: GEX March 10, 1998 Dated: Received: March 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Frod and Drug Administration (FDA) will verify such assamptions. 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. 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 requlation (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.

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): | K974536 |
|---------------------------|---------------|
| Device Name: | PhotoDerm® HR |

Indications For Use:

The PhotoDerm® HR is used for the removal of unwanted hair.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (QDE)

| (Division Sign-Off) |
|---------------------|
|---------------------|

| Division of General Restorative Devices | I2994536 |
|-----------------------------------------|----------|
| 510(k) Number | |

| Prescription Use er 21 CFR 801.109) <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use ______ |
|---------------------------------------------------------------------------------------|----|-----------------------------|
|---------------------------------------------------------------------------------------|----|-----------------------------|

(Optional Format 1-2-96)