(90 days)
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No
The summary describes a laser system for surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is clearly indicated for surgical applications requiring photothermolysis, excision, incision, ablation, vaporization, and coagulation of soft tissue, which are all therapeutic actions.
No
The device is described as an aesthetic surgical laser used for various surgical applications requiring photothermolysis, excision, incision, ablation, vaporization, and coagulation of soft tissue. It is a therapy device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components, including a laser console, articulated arm, fiber port, control panels, footswitch, handswitch, remote control, and various delivery device accessories. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for use in surgical applications requiring photothermolysis, excision, incision, ablation, vaporization, and coagulation of soft tissue. These are procedures performed directly on a patient's body.
- Device Description: The description details a laser system with components like a console, articulated arm, handpieces, and controls, all designed for delivering laser energy to tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly a surgical laser system intended for therapeutic and aesthetic procedures performed directly on a patient.
N/A
Intended Use / Indications for Use
The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Product codes
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Device Description
The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-shitched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er: Y AG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:
- a laser console and tower;
- a counterbalanced articulated arm and delivery systems;
- a fiber port and delivery systems;
- control and display panels;
- footswitch and handswitch delivery controls;
- a remote control unit; and
- a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vivo testing (was performed to demonstrate that the laser energy provided by the Coherent VersaPulse Aesthetic Surgical Lasers is equivalent to that provided by the currently marketed surgical lasers. Testing is performed to establish the biocompatibility of new delivery device materials that could potentially contact patient tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K941841, K933880 & K911830, K952636, K922935 & K922577, K935631, K944090 & K940173, K905802 & K904627, K933057, K941841, K950661, K951812 & K946304, K934486
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
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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.
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Attachment 27 510(k) Summary Statement for the Coherent VersaPulse Aesthetic Surgical Lasers
I. General Information
Coherent Medical Group Submitter: 3270 West Bayshore Road Palo Alto, CA 94303
Contact Person: Anne C. Worden
Summary Preparation Date: December 29, 1995
II. Names
APR - 1 1996
Device Names: Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories.
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories).
Predicate Devices III.
- · Laserscope Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830)
- · Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577)
- · Continuum Biomedical Med Alex 755 nm Surgical Lasers (K935631)
- · Candela TL-1 Alexandrite Laser (K944090 & K940173)
- Pfizer / Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627)
- · Continuum Multilite Er:YAG (755 nm) Surgical Laser (K933057)
- · Laserscope SmartScan Fiber Delivery Device for use with Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830)
- · Candela 10 mm Circular Spot Laser Handpiece (K950661)
- · Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304)
- · Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (577 nm and 585 nm), and KTP (532 nm) Surgical Lasers (K934486)
IV. Product Description
The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er: Y AG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:
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- · a laser console and tower;
- · a counterbalanced articulated arm and delivery systems;
- · a fiber port and delivery systems;
- · control and display panels;
- · footswitch and handswitch delivery controls;
- · a remote control unit; and
- · a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).
V. Indications for Use
The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
VI. Rationale for Substantial Equivalence
The Coherent VersaPulse Aesthetic Surgical Lasers and their delivery device accessories share the same indications for use, similar design features (including control system, wavelengths, beam quality, laser tube configuration, active medium, cooling system, and controls and displays), functional features (including power, repetition rate, energy, spot sizes and treatment areas), and therefore are substantially equivalent to the Laserscope Orion SL Series & KTP /532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830), the Continuum Biomedical Medlite 532 nm & 1064 nm Surgical Lasers (K952636, K922935 & K922577), the Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631), the Candela TL-1 Alexandrite Surgical Lasers (K944090 & K940173), the Pfizer/Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627), and the Continuum Multilite Er:YAG Surgical Laser (K933057), and to the Laserscope SmartScan Fiber Delivery Device for use with Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841), the Candela 10 mm Circular Spot Laser Handpiece (K950661), the Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304), as well as the Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (577 nm and 585 nm), and KTP (532 nm) Surgical Lasers (K934486).
Safety and Effectiveness Information VII.
In-vivo testing (was performed to demonstrate that the laser energy provided by the Coherent VersaPulse Aesthetic Surgical Lasers is equivalent to that provided by the currently marketed surgical lasers. Testing is performed to establish the biocompatibility of new delivery device materials that could potentially contact patient tissue.
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VIII. Conclusion
The Coherent VersaPulse Aesthetic Surgical Lasers were found to be substantially equivalent to similar currently marketed surgical laser devices. The Coherent VersaPulse Aesthetic Surgical Lasers share the same indications for use, similar design features, and similar functional features as the currently marketed Surgical Lasers and delivery devices. The physical test results demonstrated that the Coherent VersaPulse Aesthetic Surgical Lasers have acceptable performance characteristics.