(81 days)
Not Found
No
The device description focuses on mechanical laser beam deflection and control of scan area and speed, with no mention of AI or ML technologies.
Yes
The device is used for incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue in plastic surgery/dermatology procedures, which are therapeutic interventions.
No.
The device is used for surgical procedures such as incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue, which are all therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "motorized, laser beam deflection system" with "moving mirrors" and "controls for varying the scanned area," indicating it is a hardware accessory with mechanical components, not software only.
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 (in vitro).
- Device Function: The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a surgical accessory that uses a laser beam to directly interact with soft tissue on the patient's body. It is used for procedures like incision, excision, ablation, and debridement.
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient, not the analysis of samples taken from the patient.
Therefore, this device falls under the category of a surgical laser accessory used for direct treatment of tissue, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is indicated for incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue in Plastic Surgery/Dermatology. Plastic Surgery/Dermatology procedures encountered are: laser skin resurfacing/dermabrasion, blepharoplasty, rhinophyma, squamous cell carcinoma, buccal hemangioma, telangjectasis, the treatment of wrinkles or rhytides, and scar revision.
Product codes
Not Found
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 from 0.9 to 9 mm and completes the scan within 0.05 - 0.45 seconds. This device is used with CO2 handpieces or micromanipulators. 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, plastic surgery/dermatology procedures.
Indicated Patient Age Range
Not Found
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 (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.
The Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch) (preamended, K936109, K941312, and K936109, respectively).
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
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 6 1996
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 Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan Lasers, Inc SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch).
- Sharplan Lasers, Inc. . 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs April 4, 1996 1-800-394-2000, ext. 531
- Model: Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory 2.
- The Robbins Acrotorque & Bell Hand Engines,the Sharplan Model Predicate Devices: 3. 1120 CO2 Surgical Laser, and the Sharplan Lasers, Inc. SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch).
- 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 from 0.9 to 9 mm and completes the scan within 0.05 - 0.45 seconds. This device is used with CO2 handpieces or micromanipulators. 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 Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch) (preamended, K936109, K941312, and K936109, respectively). It is indicated for incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue in Plastic Surgery/Dermatology. Plastic Surgery/Dermatology procedures encountered are: laser skin resurfacing/dermabrasion, blepharoplasty, rhinophyma, squamous cell carcinoma, buccal hemangioma, telangjectasis, the treatment of wrinkles or rhytides, and scar revision.
REVISED APRIL 4, 1996
1
510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory
24.4411 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - -
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- From a clinical performance perspective, the aforementioned devices while are not 6. identical, perform the same function for the same indications. Regarding the technological similarities; while two of the predicated devices are of the same photonic technology with minor differences, the non-laser device relies upon a mechanical technology to achieve its therapeutic effect. Based upon the clinical information submitted, Sharplan Lasers, Inc.believes that the expanded indications for this device raises no safety or efficacy concerns.
- This information was prepared for the sole purpose of compliance with the Advisory: 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.
Revised April 4, 1986