(89 days)
Not Found
No
The description mentions "precise computer control motion" but does not use terms like AI, ML, deep learning, or describe any learning or adaptive capabilities.
Yes
The device is described as being used with a laser for "treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin," which are therapeutic applications. It is an "aesthetic surgery tool" used for "soft tissue ablation procedures" and helps perform "cosmetic procedures." The predicate devices are also therapeutic scanning devices used with lasers.
No
Explanation: The device is described as manipulating and placing a laser beam for treatment (ablation, vaporization, coagulation) of soft tissue on the skin. It does not mention any function for detecting, analyzing, or identifying medical conditions or diseases. Its purpose is purely therapeutic.
No
The device description explicitly states "SoftScan is a hand held device" and describes its function in manipulating a laser beam, indicating it is a physical hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a therapeutic or surgical procedure performed directly on a patient's body.
- Device Description: The description reinforces this by detailing how the device is used to "perform the widest range of cosmetic procedures" and "precise tissue removal."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases. This device does not perform any such analysis of biological samples.
The device is a tool used in a surgical or therapeutic procedure performed in vivo (on the body).
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device 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 emission is done by the SoftScan while leaving the physician in full control of laser emission at all times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue on the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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.
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
Image /page/0/Picture/21 description: The image shows the logo for SAHAR Technologies. The logo is in black and white and features the word "SAHAR" in a bold, stylized font. Below the word "SAHAR" is the word "Technologies" in a smaller, less bold font. The logo is simple and modern.
K 971024
SAHAR Technologies, Inc. 11772 Sorrento Valley Rd., Suite 112 San Diego, CA 92121 619 792 1451 619 792 1675 Fax
JUN 17 1997
510(k) Summary
Submitter: Sahar Technologies, Inc.
Address: 11772 Sorrento Valley Road, Suite 112 San Diego, CA 92121
Phone number: (619)792-1451
Fax number: (619)792-1675
Contact person: Shlomo Assa
Date prepared: March 17, 1997
Trade name: SoftScan
Common name: Laser Accessory
Classification name: Class II
Substantial equivalence claimed to:
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
1
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The overall design is simple and professional, reflecting the department's role in public health and human services.
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 (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
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
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 | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
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