DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM

K964031 · Slt-J , Ltd. · GEX · Dec 23, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K964031
• Device Name: DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
• Applicant: Slt-J , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DCL8 Enhanced Pulsed Nd:YAG laser system is substantially equivalent to other pulsed Nd:YAG 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 Story

Pulsed Nd:YAG laser system for soft tissue surgery; performs incision, excision, coagulation, vaporization. Input: 110 VAC power. Operation: user-controlled via touch pad; red diode aiming beam for targeting. Output: pulsed laser energy delivered via fiberoptic cables. Used in clinical settings (open, endoscopic, microscopic procedures) by physicians. Benefits: precise soft tissue management via established laser technology.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through comparison of operating characteristics and delivery system compatibility with predicate devices.

Technological Characteristics

Pulsed Nd:YAG laser; 110 VAC power source; red diode aiming beam; touch pad control interface; SMA 905 fiberoptic connector system for delivery.

Indications for Use

Indicated for incision, excision, coagulation, or vaporization of soft tissues, including subcutaneous tissues, striated and smooth muscle, mucous membranes, organs, and glands in open, endoscopic, and microscopic procedures.

Regulatory Classification

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.

Predicate Devices

• Sunrise Technologies pulsed Nd:YAG laser systems
• American Dental Technologies pulsed Nd:YAG laser systems

Submission Summary (Full Text)

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k964031

F. Summary of Safety and Effectiveness

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:

1. The DCL8 Enhanced Pulsed Nd:YAG laser system is substantially equivalent to other pulsed Nd:YAG 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.

2. The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd:YAG 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.

3. 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

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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.

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