(84 days)
No
The description focuses on precise computer control for beam deflection and timing, but there is no mention of learning, adaptation, or data-driven decision making that would indicate AI/ML.
Yes
The device is described as an aesthetic surgery tool for soft tissue ablation procedures, which implies it directly treats or alters tissue for medical or cosmetic purposes.
No
Explanation: The provided text describes the SofTouch device as a tool for soft tissue and skin treatments, specifically for performing aesthetic laser surgery and tissue removal. Its functions involve controlling laser emission placement, shape, size, and timing for treatment purposes, not for diagnosing medical conditions.
No
The device description explicitly states "SofTouch is a hand held device" and mentions "SofTouch hardware and software," indicating it includes physical components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the SofTouch is a hand-held device used for soft tissue treatments and skin treatments, specifically involving laser beam application directly to the tissue for ablation and removal. This is an in vivo (within the living body) procedure.
- Intended Use: The intended use is for treating soft tissue and skin, not for analyzing biological samples.
- Device Description: The description focuses on controlling the laser beam's placement and movement on the tissue, not on analyzing biological specimens.
The device is a tool used by a physician to perform a medical procedure directly on a patient's body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Soft tissue treatments and in particular skin treatments require a device that can cover large and variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area will enhance the precision and safety of the treatment. The timing of the emission placement on the tissue is done by the SofTouch hardware and software to avoid errors and to increase precision and homogeneity. SofTouch 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.
Product codes
Not Found
Device Description
Adding the SofTouch 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. SofTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SofTouch introduces an extra dimension of control for precise tissue resnoval using lower power than previously thought possible. The SofTouch aiming beam mode visually displays the area about to be treated on the tisme. 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 SofTouch 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, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SAHAR
Technologies
K 964684
Sh. 14, 1997
- SAHAR Technologies, Inc. 11772 Serrents 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: (619)792-1451
Fax number: (619)792-1675
Contact person: Shlomo Assa
Date prepared: November 12, 1996
Trade name: SofTouch
Common name: Laser Accessory
Classification name: Class II
Substantial courvalance claim on to:
-
Clinicon Corporation SureBoan 510(k) mumber - K962242
-
Lasersonics Parascan - 510(k) mumber - K955734
Description:
Adding the SofTouch 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. SofTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SofTouch introduces an extra dimension of control for precise tissue resnoval using lower power than previously thought possible. The SofTouch aiming beam mode visually displays the area about to be treated on the tisme. 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
3h
1
emission is done by the SofTouch while leaving the physician in full control of laser emission at all times.
Intended use:
Soft tissue treatments and in particular skin treatments require a device that can cover large and variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area will enhance the precision and safety of the treatment. The timing of the emission placement on the tissue is done by the SofTouch hardware and software to avoid errors and to increase precision and homogeneity. SofTouch 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 SofTouch 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 SofTouch 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 SofTouch improves safety by decreasing fatigue experienced by the physician during a procedure. The high bandwidth design of the SofTouch 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 SofTouch device allows for better fluence at lower power levels, which is also a net increase in safety.