(35 days)
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No
The description mentions "computer-controlled patterns" and a "CPU based Laser control system," which indicates automation and digital control, but there is no mention of AI or ML algorithms for learning, adaptation, or complex decision-making based on data.
Yes
The device is clearly indicated for surgical applications involving the excision, incision, ablation, vaporization, and coagulation and photothermolysis of soft tissue, which are all therapeutic actions.
No
The device description and intended use clearly state that the ScanTech laser scanning handpiece is designed for surgical applications involving tissue modification (e.g., excision, incision, ablation) using laser energy, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a handpiece, control/power cable, laser control/display panel interface, CPU based laser control system, CPU controlled power supply, removable spatula-bayonet tip, and screw ring attachment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The ScanTech laser scanning handpiece is described as a surgical tool used for direct interaction with soft tissue within the body (in vivo) for procedures like excision, incision, ablation, vaporization, coagulation, and photothermolysis.
- Intended Use: The intended use clearly states "surgical applications" and lists various medical specialties where it's used for treating soft tissue.
- Device Description: The description details components related to delivering laser energy for surgical procedures, not for analyzing biological samples.
The device is a surgical laser handpiece, which is a type of medical device used for treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Phantom ScanTech handpiece is intended to be used with the Phantom Family of Medical Lasers to deliver a broad spectrum of laser light energy for use in surgical applications generally requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in a variety of medical specialties.
The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology including, but not limited to use in oculoplasty.
The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology (limited to periobital dermis).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Phantom ScanTech handpiece is intended to be used with the Phantom Family of Medical Lasers to deliver a broad spectrum of laser light energy for use in surgical applications generally requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in a variety of medical specialties.
The Phantom ScanTech handpiece is composed of the following main components:
Handpiece with dual galvo X - Y scanning capabilities Control / power cable Laser control / display panel interface CPU based Laser control system CPU controlled power supply Removable spatula-bayonet tip Screw ring attachment for articulated arm
Used in conjunction with the Phantom Family of Medical Lase automated scanning device to accurately and quickly apply computer-controlled patterns of various shapes and sizes. The Physician, or his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen.
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, periobital dermis
Indicated Patient Age Range
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Intended User / Care Setting
Physician, or his/her assistant
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)
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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.
K960032, K951812, K943604, K962242, K964520, K955734, K941841, K964684, K961935, K960820, K960521, K955621
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.
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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.
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