K Number
K964031
Device Name
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
Manufacturer
Date Cleared
1996-12-23

(76 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures.
Device Description
The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems.
More Information

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Not Found

No
The summary describes a laser system with standard operating characteristics and controls, with no mention of AI, ML, image processing, or data-driven performance metrics.

Yes
The device is used for "incision, excision, coagulation or vaporization of soft tissues," which are therapeutic procedures.

No

The device description indicates it is a laser system used for procedures like incision, excision, coagulation, or vaporization of soft tissues, which are therapeutic actions, not diagnostic ones.

No

The device description clearly details hardware components such as a laser system, aiming beam, touch pad controls, power input, and fiberoptic connector system.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes procedures performed on the body (incision, excision, coagulation, vaporization of soft tissues) using a laser. IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a person's health.
  • Device Description: The description details a laser system used for surgical procedures, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostics.

This device is clearly intended for surgical or therapeutic use, not for diagnostic testing performed outside of the body.

N/A

Intended Use / Indications for Use

The DCL8 Enhanced Pulsed Nd:YAG laser system is substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures.

Product codes

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Device Description

The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd:YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector systems used by Sunrise Technologies and American Dental Technologies.

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 tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands

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)

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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.

0

964631/

Summary of Safety and Effectiveness F.

DEC 23 1996

The DCL8 Enhanced Pulsed Nd: YAG laser system is substantially equivalent to other pulsed Nd: YAG laser systems currently marketed by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Troy, MI)

This belief is based upon the following facts:

  • The DCL8 Enhanced Pulsed Nd:YAG laser system is 1. substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures. The delivery systems which can be used in conjunction with the DCL8 Enhanced Pulsed Nd:YAG laser system have previously been cleared for marketing by the FDA.
    1. The DCL8 Enhanced Pulsed Nd: YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies.
    1. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector systems used by Sunrise Technologies and American Dental Technologies. The delivery systems which will be used with the DCL8

002̄1-a

1

Enhanced Pulsed Nd: YAG laser system have previously received market clearance for use with Nd:YAG laser systems to which the delivery systems can be attached.

?

0022-a