LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER

K960636 · Heraeus Surgical, Inc. · GEX · Aug 21, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960636
• Device Name: LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER
• Applicant: Heraeus Surgical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd:YAG soft tissue applications.

Device Story

Sterile, disposable fiberoptic delivery system; designed for use with Nd:YAG laser systems. Transmits laser energy to target soft tissue; enables contact and coagulation. Used in clinical settings by physicians; facilitates surgical procedures requiring soft tissue management. Benefits include precise energy delivery for coagulation; consistent with established laser surgery practices.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate device.

Technological Characteristics

Cylindrically diffusing fiberoptic delivery system; designed for use with Nd:YAG laser systems. Complies with 21 CFR 1040.10 and 1040.11. Sterile, disposable form factor.

Indications for Use

Indicated for soft tissue contact and coagulation in patients requiring procedures cleared for LaserSonics Nd:YAG laser systems.

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

• Dornier ThermaFocus 360™ Fiber

Submission Summary (Full Text)

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AUG 21 1996
K960636

# 2. SUMMARY OF SAFETY AND EFFECTIVENESS

Heraeus Surgical, Inc. Premarket Notification for Cylindrically Diffusing Fiber

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SUMMARY OF SAFETY AND EFFECTIVENESS
LASERSONICS Nd:YAG CYLINDRICALLY DIFFUSING
STERILE DISPOSABLE FIBER

REGULATORY AUTHORITY:

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT:

Alan Curtis,
Director Regulatory Affairs/Quality Assurance
Heraeus Surgical, Inc.
575 Cottonwood Drive
Milpitas, CA 95035-7434
Phone: [phone]
FAX: [phone]

DEVICE TRADE NAME:

LaserSonics Nd:YAG Cylindrically Diffusing Sterile Disposable Fiber

DEVICE COMMON NAME:

Cylindrically Diffusing Fiber

Note: LaserSonics is a division of Heraeus Surgical, Inc., located at the same address.

Heraeus Surgical, Inc. Premarket Notification for Cylindrically Diffusing Fiber

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# SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2

## DEVICE CLASSIFICATION:

To the best of our knowledge, laser fiberoptic delivery systems have not been classified by the FDA. The Nd:YAG laser systems on which the sterile disposable fibers are intended for use have been classified as Class II (79 GEX) Medical Devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.

## PERFORMANCE STANDARDS:

Heraeus Surgical is unaware of any specific standards for laser fiberoptic delivery systems. The laser systems manufactured by Heraeus Surgical comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.

## INDICATIONS FOR USE STATEMENT:

The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd:YAG soft tissue applications.

DEVICE DESCRIPTION-DIFFUSING MATERIAL

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SUMMARY OF SAFETY AND EFFECTIVENESS,
PAGE 3

## COMPARISON WITH PREDICATE DEVICE:

In the opinion of Heraeus Surgical, the Cylindrically Diffusing Fiber is equivalent to the Dornier ThermaFocus 360™ Fiber. These devices are in all aspects equivalent.

The risks and benefits of the Cylindrically Diffusing Fiber are comparable to the predicate device when used for similar clinical applications.

Since the Cylindrically Diffusing Fiber is substantially equivalent with respect to indication for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonable assured, therefore justifying 510(k) clearance.

Heraeus Surgical, Inc. Premarket Notification for Cylindrically Diffusing Fiber