(165 days)
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No
The description focuses on mechanical laser beam deflection and control, with no mention of AI or ML concepts.
No.
Explanation: The device is an accessory that redirects a focused laser beam for soft tissue incision during laser-assisted hair transplantation. While it aids in a medical procedure, its function is for surgical incision, not for treating a disease or condition itself.
No
The device is described as a motorized laser beam deflection system for soft tissue incision in hair transplantation, not for diagnosis.
No
The device description clearly states it is a "motorized, laser beam deflection system" with "moving mirrors" and "controls for varying the scanned area setting the exposure time." This indicates a physical hardware component that interacts with a laser, 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 is for "soft tissue incision of recipient sites for laser assisted hair transplantation." This is a surgical procedure performed directly on a living patient's tissue.
- Device Description: The device is a laser accessory used to manipulate a laser beam for surgical purposes. It interacts directly with the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
Therefore, this device falls under the category of a surgical laser accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
It is indicated for soft tissue incision of recipient sites for laser assisted hair transplantation.
Product codes
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Device Description
The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the SilkTouch Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels. The SilkTouch Flash Scanner has controls for varying the scanned area setting the exposure time. This device is used with a CO2 handpiece. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.
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
soft tissue
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)
Norcross Scientific SurgiScan CO2 Scanner, A-Z Surgical Super Punch, Robbins Acrotorque Hand Engine.
Reference Device(s)
Not Found
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
K 96 1935
510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Norcross Scientific SurgiScan CO2 Scanner, the A-Z Surgical Super Punch, and the Robbins Hand Engine.
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- Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs May 6, 1996 1-800-394-2000, ext. 531
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- Model: Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory
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- Predicate Devices: Norcross Scientific SurgiScan CO2 Scanner, the A-Z Surgical Super Punch, the Robbins Acrotorque Hand Engine.
- Description: The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a 4 . motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the SilkTouch Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels The SilkTouch Flash Scanner has controls for varying the scanned area setting the exposure time. This device is used with a CO2 handpiece. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.
- 5 . The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is substantially equivalent to the following devices: the Norcross Scientific SurgiScan CO2 Scanner, the A-Z Surgical Super Punch, and the Robbins Acrotorque Hand Engine. It is indicated for soft tissue incision of recipient sites for laser assisted hair transplantation.
1
510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory
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- From a clinical performance perspective, the aforementioned devices while are not identical, perform the same function for the same indication. Regarding the technological similarities; while two of the predicate devices are of the same photonic technology with minor differences, the non-laser devices relies upon a mechanical technology to achieve its clinical effect. Based upon the histological information submitted, Sharplan Lasers, Inc. believes that the expanded indications for this device raises no safety or efficacy concerns.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.