(58 days)
Not Found
No
The description mentions "precise microprocessor control motion" for beam deflection, which is a form of automated control, but it does not describe any learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
Yes
The device is described as an "aesthetic surgery tool" used for "treatment of any soft tissue, including ablation, vaporization, and coagulation of soft tissue on the skin" and "cosmetic procedures," which are therapeutic applications.
No
Explanation: The device is described as a tool for manipulating and placing a laser beam for treatment purposes (ablation, vaporization, coagulation of soft tissue), not for diagnosing conditions.
No
The device description clearly states that SureTouch is added to a laser and involves microprocessor control motion to deflect the laser beam, indicating it is a hardware component that interacts with and controls a laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SureTouch 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 device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on how the device controls a laser beam for tissue removal and aesthetic procedures. It describes a tool for performing procedures directly on the patient's skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), providing diagnostic information, or being used in a laboratory setting.
Therefore, SureTouch is a therapeutic laser accessory used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SureTouch 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 SureTouch to a laser will convert the system into a sophisticated, easy to use aestheric surgery tool that can perform the widest range of cosmetic procedures. SureTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where of micro-ablation is required. SureTouch introduces an extra dimension of control for precise tissue removal. The SureTouch aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physicians can change the shapes and sizes. The aiming beam outline will change, continuously displaying the area that is about to be treated.
Filling in the displayed area is performed using a precise microprocessor control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. The SureTouch coordinates the laser emission while leaving the physician in full control of laser output at all times.
Summary of technological characteristics:
Technologically, the SureTouch Scanning System offers all of the features and functionality of the Sahar Technologies SoftScan and SofTouch scanning systems. The SureTouch offers greater flexibility than other scanning systems 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. The SureTouch Scanning System utilizes 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,
The SureTouch improves safety by decreasing fatigue experienced by the physician caused by the normally tedious nature of applying single spot laser energy over large areas.
The improved performance of the SureTouch device allows for better fluence at lower power levels, which is also a net increase in safety.
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 / dermatological applications; aesthetic laser surgery
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.
K971024, K964684, K962242, K955734
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
APR 2 9 1998
510(k) Summary
Submission: Sahar Technologies, Inc.
Address: 3940 Ruffin Road, Suite C San Diego, CA 92123 USA
Phone: 619-277-7086
Fax: 619-277-7874
Contact: Gary Shaffer
Date: 1/20/98
Trade name: SureTouch
Common name: Laser scanner
Regulatory class: II
Product code: GEX
Substantial equivalence claimed to:
- Sahar Technologies Inc. SoftScan; 510(k) number K971024 1.
- Sahar Technologies Inc. SofTouch; 510(k) number K964684 2.
- Clinicon Corporation SureScan; 510(k) number K962242 3.
- Lasersonics Parascan; 510(k) number K955734 4.
Description:
Adding the SureTouch to a laser will convert the system into a sophisticated, easy to use aestheric surgery tool that can perform the widest range of cosmetic procedures. SureTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where of micro-ablation is required. SureTouch introduces an extra dimension of control for precise tissue removal. The SureTouch aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physicians can change the shapes and sizes. The aiming beam outline will change, continuously displaying the area that is about to be treated.
Filling in the displayed area is performed using a precise microprocessor control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. The SureTouch coordinates the laser emission while leaving the physician in full control of laser output at all times.
1
Intended use:
Treating large and variable areas of soft tissue on the skin with a laser requires a device that can manipulate and place the pulsed or CW emission in a safe and consistent manner. The SureTouch provides the means to cover small and large areas of skin tissue with precise 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 enhances the precision and safety of the treatment. A variety of dermatological applications are enhanced by the precise control of laser emission the SureTouch enables. SureTouch will be used to manipulate and place a pulsed and/or CW laser beam for use in dermatological applications including ablation, vaporization, and coagulation of soft skin tissue.
Summary of technological characteristics:
Technologically, the SureTouch Scanning System offers all of the features and functionality of the Sahar Technologies SoftScan and SofTouch scanning systems. The SureTouch offers greater flexibility than other scanning systems 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. The SureTouch Scanning System utilizes 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,
The SureTouch improves safety by decreasing fatigue experienced by the physician caused by the normally tedious nature of applying single spot laser energy over large areas.
The improved performance of the SureTouch 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. Encircling the graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Shaffer ·Regulatory Affairs Manager Sahar Technologies, Incorporated 3940 Ruffin Road, Suite C San Diego, California 92123
Re: K980784 SureTouch Trade Name: Regulatory Class: II Product Code: GEX January 20, 1998 Dated: Received: March 2, 1998
Dear Mr. Shaffer:
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 The general controls provisions of the Act 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. ਸੇ 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 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 regulations.
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Page 2 - Mr. Shaffer
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 (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
4
K980784 510(k) Number (if known):
Device Name: SureTouch
Indications for Use:
SureTouch 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
P. colles
Divisio Division of General Restorative Devices 510(k) Number
Prescription Use
Over-the-Counter Use