(27 days)
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No
The summary describes a standard Er:YAG laser device with no mention of AI or ML features, image processing, or data sets typically associated with AI/ML applications.
Yes
The device is indicated for intraoral soft tissue surgery, which is a therapeutic intervention.
No
The device is indicated for intraoral soft tissue surgery, not for diagnosing conditions. It is a laser used for treatment.
No
The device description clearly states it is an Er:YAG laser with physical components (lasing medium, foot switch, weight, size, electrical requirements), indicating it is a hardware device, not software-only.
Based on the provided information, the Smart 2940 D laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "intraoral soft tissue surgery including dental soft tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a laser device used for surgical applications, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Smart 2940 D laser is a medical device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smart 2940 D laser is indicated for intraoral soft tissue surgery.
The Smart 2940 D laser is indicated for intraoral soft tissue surgery including dental soft tissue.
Product codes
GEX
Device Description
Smart 2940 D is an Er:YAG laser, having a flashlamp pumped, Erbium rod as the lasing medium. It is a laser with a wavelength of 2,940 nm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
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
intraoral 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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
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Predicate Device(s)
PhotoDent laser
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.
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