DERMA K LASER SYSTEM

K972872 · Esc Medical Systems , Ltd. · GEX · Oct 28, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972872
• Device Name: DERMA K LASER SYSTEM
• Applicant: Esc Medical Systems , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Derma™ K is drawn from that of the predicates Derma™ 20 and Topaz™ 30, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of: Dermatology Cosmetic Surgery Plastic and General Surgery Dental and Oral Surgery Gynecology Orthopedic Otorhinolaryngology (ENT) Podiatry

Device Story

Derma™ K is a dual-wavelength surgical laser system producing infrared energy at 2.94 microns (Er:YAG) and 10.6 microns (CO2). Energy is delivered to soft tissue via an articulated arm and removable handpieces. Operated by physicians in clinical or surgical settings, the device performs incision, excision, ablation, vaporization, and hemostasis. The system utilizes electronic control and cooling systems to manage laser output. By providing precise tissue interaction, the device assists surgeons in various specialties, potentially improving procedural outcomes compared to traditional surgical methods.

Clinical Evidence

No clinical data submitted. Bench testing only.

Technological Characteristics

Dual-wavelength laser system (Er:YAG 2.94 microns; CO2 10.6 microns). Features articulated arm delivery with removable handpieces. Includes electronic control systems, cooling systems, and aiming beam diode laser. Identical to predicate systems in power, wavelength, and construction. Class II device.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and hemostasis of soft tissue in patients requiring surgical intervention in dermatology, cosmetic, plastic, general, dental, oral, gynecologic, orthopedic, ENT, and podiatric specialties.

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

• ESC Topaz™ 30 Laser System (K965015)
• ESC DermaTM 20 Laser System (K964253)

Submission Summary (Full Text)

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#### 510(K) Summary 4.

# OCT 28 1997

### Summary Page 1 of 2

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

K972872

- Submitter's name, address, telephone, fax, & contact person 1 .
Dr. Zvi Ladin ESC Medical Systems Limited Title: Vice President, Clinical Applications and Regulatory Affairs Phone: [phone] Fax: [phone] Address: Yokneam Industrial Park, PO Box 240, Yokneam 20692, Israel

- 2. Date summary prepared:
July 31, 1997

- 3. Product trade or proprietary name: Derma™ K laser system
- 4. Product common name: Dual wavelength Er: YAG and CO2 Laser System

#### న్. Product classification name 21C.F.R. § 878.4810 Lasers in general and plastic surgery and in dermatology 21C.F.R. § 874.4500 Lasers for use in ENT 21C.F.R. § 884.4550 Gynecologic surgical laser

#### Legally marketed predicates device used for equivalency: 6.

ESC Topaz™ 30 Laser System (K965015)

ESC DermaTM 20 Laser System (K964253)

- 7. Description:
The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.

ESC Proprietary Information

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### Summary Page 2 of 2

- 8. Statement of intended use:
The intended use of the Derma™ K is drawn from that of the predicates Derma™ 20 and Topaz™ 30, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:

- · Dermatology
- · Cosmetic Surgery
- · Plastic and General Surgery
- · Dental and Oral Surgery
- · Gynecology
- · Orthopedic
- · Otorhinolaryngology (ENT)
- Podiatry

#### Clinical and Non-clinical Performance Data 9.

None submitted.

- Technological characteristics: 10.
The Er: YAG laser output characteristics of the Derma™ K system and the predicate Derma™ 20 system are identical in average power, increments of power available, and wavelength. The electronic control systems, safety systems, cooling systems, Er: YAG laser, and aiming beam diode laser are identical.

The CO2 laser output characteristics of the Derma™ K system and the predicate ESC Topaz™ 30 system are similar in average power, increments of power available, and wavelength. The laser and power source are identical in construction.

There are no technological characteristics of the Derma™ K that are different from the predicates.

Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients or operators due to operator error or in high risk procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 28 1997

Dr. Zvi Ladin Vice President, Clinical Applications and Regulatory Affairs ESC Medical Systems, Ltd. Yokneam Industrial Park, PO Box 240 Yokneam 20692, Israel

Re: K972872 Trade Name: DERMA™ K Laser System Regulatory Class: II Product Code: GEX Dated: July 31, 1997 Received: August 4, 1997

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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 [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,

toscella

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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K972872

510(k) Number (if known):

Derma™ K Laser System Device Name: ...

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:

Indications For Use:

The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K972872 |

Prescription Use (Per 21 CFR 801.109)

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