DIOMED 15, 30, 60 SURGICAL DIODE LASER

K962354 · Lifestream Int'L, Inc. · GEX · Sep 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962354
• Device Name: DIOMED 15, 30, 60 SURGICAL DIODE LASER
• Applicant: Lifestream Int'L, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.

Device Story

Class IV GaAlAs diode laser system; 805nm wavelength; 650nm aiming beam. Modifications to predicate Diomed 25W laser include power output scaling (15W, 30W, 60W models) and expanded soft tissue indications. 15W model utilizes eight 2W diodes; 30W model utilizes sixteen 2W diodes; 60W model utilizes sixteen 4W diodes. Power supply and cooling systems scaled accordingly; mechanical design and user interface unchanged. Used by surgeons in open and endoscopic procedures for soft tissue management. Delivers continuous wave radiation via flexible optical fiber. Clinical benefit includes precise tissue ablation, incision, and coagulation across multiple surgical specialties.

Clinical Evidence

Bench testing validated unit and system-level specifications. Canine tissue studies compared performance to existing Nd:YAG lasers, demonstrating equivalent tissue damage profiles and performance characteristics.

Technological Characteristics

Class IV GaAlAs diode laser; 805nm treatment wavelength; 650nm aiming beam. Power output: 15W, 30W, or 60W continuous wave. Delivery via flexible optical fiber. System includes scaled power supply and cooling architecture. Mechanical design and user interface consistent with predicate.

Indications for Use

Indicated for soft tissue ablation, incision, excision, coagulation, and vaporization in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic procedures. Applicable for both contact and non-contact use.

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

• Diomed 25 Surgical Diode Laser

Submission Summary (Full Text)

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510(k) Summary for
Modifications to the Diomed Surgical Diode Laser

SEP 11 1996
K962354

1. Date Summary Prepared

June 17, 1996

2. Submitter's Name and Address

Surgimedics/ESP
2828 N. Crescent Ridge Drive
The Woodlands, TX 77381

Contact Person: Mr. Donald F. Hults
Phone Number: [phone]
Fax Number: [phone]

3. Device Name

Trade/Proprietary Name: Diomed 15 Surgical Diode Laser
Diomed 30 Surgical Diode Laser
Diomed 60 Surgical Diode Laser
Common Name: Laser, GaAlAs - Diode

4. Predicate Device

The legally marketed device to which equivalence is being claimed is:

Diomed 25 Surgical Diode Laser

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# 5. Device Description

The Diomed Surgical Diode Laser is a Class IV GaAlAs (Gallium Arsenide) diode laser with a wavelength of $805\mathrm{nm}$ and a visible (aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of $650\mathrm{nm}$.

The Diomed 15/30/60 Watt Surgical Diode Lasers are modifications to the maximum power output rating of the original Diomed 25 Watt Diode Surgical Laser. The modifications are in three areas:

**Labeling:** The Diomed 25 Surgical Diode Laser will be renamed (relabeled) to the Diomed 30 Surgical Diode Laser. This change is being made to be consistent with the industry practice of designating a laser’s power based on the output power at the laser port rather that at the tissue site. There is no change in construction or performance of this device.

**Power Output:** Two additional models will be created by doubling and halving the output power to produce the Diomed 15 15W Surgical Diode Laser and the Diomed 60 60W Surgical Diode Laser, respectively. The same basic design is retained. The 15 Watt model uses eight 2 Watt laser diodes, the 30 Watt model uses sixteen 2 Watt laser diodes, and the 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new models have been appropriately scaled, while the mechanical design and user interface remain unchanged.

**Indication For Use:** The indications for the three models are expanded to include both contact and non-contact use for the following soft tissue applications:

- General Surgery
- Ophthalmology/Oculoplastic
- Urology
- Gastroenterology
- Gynecology
- Otorhinolaryngology
- Pulmonary/Thoracic
- Dermatology/Plastic Surgery
- Neurosurgery (coagulation only)
- Orthopedic

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6. Intended Use

The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.

7. Comparison of Technological Characteristics

The modification replaces the Diomed 25 Surgical Diode Laser with three new models, the Diomed 15, 30, and 60 Surgical Diode Lasers. Modifications are to offer models with different maximum output powers (15, 30, and 60 Watts at the output port), in order to provide sufficient power when it is required, and to provide a more cost effective device for applications that do not require the higher power capabilities. The Diomed 25 Surgical Diode Laser currently operates with a maximum output power of 30 Watts at the output port. In addition indications for use have been expanded to include both contact and non-contact treatment of soft tissues applications for which legally marketed lasers are currently available.

8. Nonclinical Tests Used in Determination of Substantial Equivalence

The design of the Diomed surgical Diode Lasers has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied.

Canine tissue studies demonstrate equivalent performance between the Diomed Surgical Diode Laser and predicate laser systems, and concludes that tissue damage effects of the Diomed Surgical Diode Laser do not exceed those of existing Nd:YAG lasers.

9. Conclusions From Nonclinical Testing

The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate device prior to the modifications.

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