(84 days)
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No
The description focuses on automated adjustments based on pre-programmed patterns and scan speed, not learning or adaptive behavior characteristic of AI/ML. There are no mentions of AI, ML, or related terms, nor descriptions of training or test data sets.
Yes
The device is used for soft tissue ablation procedures, which are therapeutic interventions aimed at removing tissue to treat a medical condition or symptom.
No
The device is used for soft tissue ablation procedures, which involve treating or removing tissue. It does not perform any diagnostic function.
No
The device description explicitly states it "converts any CO2 laser... into a sophisticated aesthetic surgery laser system" and mentions features like "scan speed," "collimated beam," and "scan outline and size displayed on the tissue." This indicates it is a hardware component that interfaces with and controls a laser, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue ablation procedures where precise removal is required." This describes a surgical or therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The description details how the device works with a CO2 laser to perform ablation procedures. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the SureScan device, as described, falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SureScan may be used for a variety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers.
Product codes
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Device Description
SureScan converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures. It comes equipped with six different patterns in 26 different sizes. It automatically adjusts the scan speed to ensure uniform laser ablation which eliminates charring and thermal damage. The collimated beam ensures constant power density and tissue removal at any working distance. The SureScan has an adjustable spot overlap density for more precision and control. The Scan outline and size are clearly displayed on the tissue, allowing precise placement of the laser energy and subsequent scan shapes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
3 1996
CLINICON CORPORATION 2182 El Camino Real, Suite 209 OCEANSIDE, CA 92054, USA Telephone: 619 721 1100
510(k) Summary
Submitter: Clinicon Incorporated
Address: 2182 El Camino Real, Suite 209 Oceanside, CA 92054
Phone number: 619-721-1100
Fax number: 619-721-1106
Contact person: Alan Bunting
Date prepared: June 6, 1996
Trade name: SureScan
Common name: Laser Accessory
Classification name: Class II
Substantial equivalence claimed to:
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- Lasersonics Parascan 510(k) number K955734
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- Coherent Computerized Pattern Generator
Description:
SureScan converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures. It comes equipped with six different patterns in 26 different sizes. It automatically adjusts the scan speed to ensure uniform laser ablation which eliminates charring and thermal damage. The collimated beam ensures constant power density and tissue removal at any working distance. The SureScan has an adjustable spot overlap density for more precision and control. The Scan outline and size are clearly displayed on the tissue, allowing precise placement of the laser energy and subsequent scan shapes.
1
Intended use:
SureScan may be used for a variety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. Using advanced software control. SureScan juxtaposes laser beam spots with precisely controlled amounts of spatial overlap and time between overlap spots. Highly controlled tissue ablation is achieved with minimal thermal injury. The microprocessor controlled failsafe system eliminates potential hazards because the operation is controlled via an existing laser footswitch, so there is no interference with the internal electronics or the laser. SureScan allows for realignment of a laser beam due to an out of calibration articulated arm. As a result, the physician is always assured of optimum beam quality and mode as it exits the SureScan Device. If the beam characteristics of the laser do not meet the control standards of the SureScan system, an audible warning is provided to the operator and the laser footswitch rendered inoperative.
Summary of technological characteristics:
SureScan adjusts scan speed of the laser beam over tissue according to the specifications of the laser to ensure uniform ablation. Conventional spiral scanners use constant velocity mirror rotation to scan the laser beam in an outward spiraling circular pattern. This results in deeper ablation at the center if laser power is held constant during the scan cycle and has the potential for scarring and or hyperpigmentation.
Different sized squares, rectangles, ellipses, triangles, hexagons, parallelograms and lines may be selected and automatically ablated in a single scan cycle. The results allow for more predictable and controlled tissue effect to optimize treatment results.