SOFTSCAN

K971024 · Sahar Technologies, Inc. · GEX · Jun 17, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971024
• Device Name: SOFTSCAN
• Applicant: Sahar Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treating soft tissue on the skin with a laser requires a device that can manipulate and place the pulsed or CW emission by covering large and variable areas in a safe and consistent way. The SoftScan provides the ability to cover small and large area of soft tissue on the skin while having control of the emission placement. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and size that best fits the treated area will enhance the precision and safety of the treatment. The timing of the emission placement on the skin is done by the SoftScan hardware and software to avoid errors and to increase precision and homogeneity. SoftScan is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.

Device Story

SoftScan is a handheld laser accessory designed for aesthetic surgery and dermatology. It attaches to existing laser systems to convert them into tools for precise soft tissue ablation, vaporization, and coagulation. The device uses an aiming beam to visually display the treatment area on the patient's skin. The physician selects the desired shape and size of the treatment area, and the device's microprocessor-controlled scanning system deflects the laser beam to ensure accurate, homogeneous energy delivery. This automation reduces physician fatigue associated with manual spot-by-spot application and allows for effective treatment at lower power levels. The physician maintains control over laser emission at all times. The device is intended for use by clinicians in a clinical setting to improve treatment precision, safety, and consistency across variable skin areas.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled laser scanning system; handheld form factor; compatible with pulsed or CW laser emissions; high-bandwidth design for precise beam deflection; provides homogeneous energy application; intended for integration with existing laser systems.

Indications for Use

Indicated for use in dermatology for the treatment of soft tissue, including ablation, vaporization, and coagulation of soft tissue on the skin using pulsed or CW laser beams.

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

• Clinicon Corporation SureScan (K962242)
• Lasersonics Parascan (K955734)

Reference Devices

• Coherent CPG

Submission Summary (Full Text)

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SAHAR
Technologies
K 971024
JUN 17 1997

SAHAR Technologies, Inc.
11772 Sorrento Valley Rd., Suite 112
San Diego, CA 92121
619 792 1451
619 792 1675 Fax

510(k) Summary

Submitter: Sahar Technologies, Inc.

Address: 11772 Sorrento Valley Road, Suite 112
San Diego, CA 92121

Phone number: [phone]

Fax number: [phone]

Contact person: Shlomo Assa

Date prepared: March 17, 1997

Trade name: SoftScan

Common name: Laser Accessory

Classification name: Class II

Substantial equivalence claimed to:
1. Clinicon Corporation SureScan 510(k) number - K962242
2. Lasersonics Parascan - 510(k) number - K955734

Description:

Adding the SoftScan to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. SoftScan may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SoftScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The SoftScan aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.

Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser

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emission is done by the SoftScan while leaving the physician in full control of laser emission at all times.

## Intended use:

Treating soft tissue on the skin with a laser requires a device that can manipulate and place the pulsed or CW emission by covering large and variable areas in a safe and consistent way. The SoftScan provides the ability to cover small and large area of soft tissue on the skin while having control of the emission placement. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and size that best fits the treated area will enhance the precision and safety of the treatment. The timing of the emission placement on the skin is done by the SoftScan hardware and software to avoid errors and to increase precision and homogeneity. SoftScan is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.

## Summary of technological characteristics:

Technologically, the SoftScan Scanning System offers all of the features and functionality of the Clinicon Surescan and Lasersonic's Parascan, which both offer features and functionality in excess of the Coherent CPG. The SoftScan offers greater flexibility than the others in terms of different wavelength specific applications.

Microprocessor controlled scanning systems in general bring improved safety to the laser marketplace due to the increased control, precise placement, and homogeneous application of laser energy.

Because of the normally tedious nature of applying single spot laser energy over large areas, the SoftScan improves safety by decreasing fatigue experienced by the physician during a procedure. The high bandwidth design of the SoftScan system offers scanner capabilities previously unavailable in any application other than CO2 soft tissue, extending the safety and effectiveness improvements to a broader range of procedures.

The improved performance of the SoftScan device allows for better fluence at lower power levels, which is also a net increase in safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 17 1997

Mr. Shlomo Assa
President
SAHAR Technologies, Inc.
11772 Sorrento Valley Road, Suite 112
San Diego, California 92121

Re: K971024
Trade Name: SoftScan
Regulatory Class: II
Product Code: GEX
Dated: March 17, 1997
Received: March 20, 1997

Dear Mr. Assa:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Mr. Shlomo Assa

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,


Enclosure

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510(k) Number (if known): K 971024

Device Name: SoftScan

Indications for Use:

SoftScan will be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971024

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

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