AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM

K961710 · Applied Optronics Corp. · GEX · Nov 1, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961710
• Device Name: AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
• Applicant: Applied Optronics Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties: Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery

Device Story

The AOC Phase II 25 is a compact, air-cooled, fiber-coupled diode laser system. It utilizes indium gallium aluminum on gallium arsenide semiconductor diodes to generate 980 nm laser energy. The system is operated by physicians in clinical settings using a front-panel interface, footswitch, or handswitch. It features a visible aiming laser for targeting and supports continuous or pulsed output modes. The device delivers laser energy through disposable optical fibers to perform surgical tasks like incision, excision, coagulation, and vaporization. By providing precise, adjustable power, it enables surgeons to manage tissue effects during procedures. The system's modular design and forced-air cooling eliminate the need for water cooling, facilitating reliable, maintenance-free operation.

Clinical Evidence

No clinical test data submitted. Bench testing confirmed rated power and wavelength output. Peer-reviewed literature on 980 nm tissue interaction provided.

Technological Characteristics

Solid-state diode laser; 980 nm wavelength (range 970-1000 nm); indium gallium aluminum on gallium arsenide semiconductor material. Forced-air cooling; SMA-905 fiber connectors. Microprocessor-controlled; menu-driven interface. Continuous, single, repeat, and exponential pulse modes. Safety features include interlocks, aiming beam, and audible/visual indicators.

Indications for Use

Indicated for patients requiring surgical incision, excision, coagulation, or vaporization in urology, gynecology, gastroenterology, pulmonology, general/thoracic surgery, neurosurgery (hemostasis), ENT/head/neck surgery, and dermatology/plastic surgery.

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

• AOC 25 (980 nm Diode Laser)
• Cynosure Phototome (980 nm Diode Laser)
• Cytocare DioLase HP-1 (980 nm Diode Laser)
• DioMed 25 (810 nm Diode Laser)
• Indigo Medical IDE 830E (830 nm Diode Laser)
• Sharplan Lasers 6020 (810 nm Diode Laser)

Submission Summary (Full Text)

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APPLIED OPTRONICS CORP.
K 961710
111 Corporate Blvd. • Building J • South Plainfield, NJ 07080
TEL [phone] • FAX [phone]
NOV - 1 1996

# SECTION K

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

### 1. Submitter Information

AOC Medical Systems
A Division of Applied Optronics Corporation
111 Corporate Blvd. Building J
South Plainfield, NJ 07080
Telephone: [phone]
Fax: [phone]
Contact Person: Douglass Mead
Regulatory Affairs
Date Prepared: April 30, 1996

### 2. Model AOC Phase II 25 Surgical Diode Laser

### 3. Predicate or Legally Marketed Devices:

| Manufacturer | Model | Laser Type |
| --- | --- | --- |
| AOC Medical Sys. | AOC 25 | 980 nm Diode Laser |
| Cynosure | Phototome | 980 nm Diode Laser |
| Cytocare | DioLase HP-1 | 980 nm Diode Laser |
| DioMed | DioMed 25 | 810 nm Diode Laser |
| Indigo Medical | IDE 830E | 830 nm Diode Laser |
| Sharplan Lasers | 6020 | 810 nm Diode Laser |

### 4. General System Description

The AOC Medical Systems Model Phase II 25 Fiber-Coupled Diode Laser System delivers up to 25 watts of CW optical power from a compact, air cooled unit. It is a complete, self-contained instrument, including a high efficiency power supply, an adjustable light output with constant current operation and a visible aiming laser. The system couples the laser light into high numerical aperture delivery fibers fitted with standard SMA-905 fiber connectors.

The diode lasers in this unit were fabricated by Applied Optronics Corp. from single quantum well, strained-layer, indium gallium aluminum on gallium arsenide semiconductor material. The diode lasers are sealed in

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a rugged, factory-aligned, environmentally protective module. High electrical efficiency of the diode lasers eliminate the need for water cooling and assure low maintenance, reliable laser operation for this all-solid-state system. Each individual diode laser emits at a narrow wavelength; however coupling several diodes through a fiber optic bundle results in each diode wavelength contributing to a broader spectrum emitted form the final delivery fiber. The laser energy is centered at 980nm with a total range from approximately 970-1000nm.

The AOC Phase II 25 has a modular design comprised of:

- Laser Diode and Cooling Module containing the laser diodes, the heat sink and fans.
- Optics Module containing a beamsplitter pick-off for display of the total optical power.
- Front panel for simple control of the unit.
- Transformer isolated power supplies and control electronics.

Unique attributes of this system include the following:

- Multiple, individually fiber-coupled, high power diode lasers mounted on a large thermal footprint to allow sustained high power CW operation without water cooling.
- Optical power level continuously adjustable from the front panel, with display of optical output power.
- Low power, visible aiming laser for beam targeting prior to activation of the high power lasers. The aiming laser is controlled independently of the high power lasers.
- Immediate turn-on capability. No warm-up period. No system alignments or maintenance to be made by the user.
- Forced air cooling (no water). Maximum inlet air temperature 30° C.
- Individually replaceable, fiber pigtailed diode lasers. Repairs performed at factory.

The microprocessor controlled AOC Phase II 25 diode laser system is designed to allow easy and safe operation of the laser using controls common to other surgical laser systems. The laser system utilizes a menu driven set-up operation for user prompts and program entry. The laser can be set for continuous output or programmed for single or repeat pulses at output powers up to 25 watts. A footswitch or handswitch, activated by the user, always controls laser output. An optional remote control for use in a sterile plastic dressing (e.g., standard OR microscope drape) allows the user to change the power and activate Ready and Standby Modes.

The following pre-packaged, presterilized disposable optical fibers are available for use with the AOC Phase II 25 laser system:

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| Fiber Model | Type |
| --- | --- |
| AOC DCLF-600 | 600μm Conical tip |
| AOC DCLF-1000 | 1000μm Conical tip |
| AOC DCLF-600B | 600μm Hemispherical Ball tip |
| AOC DCLF-1000B | 1000μm Hemispherical Ball tip |
| AOC DBLF-60S | 600μm Side firing |
| AOC DBLF-100S | 1000μm Side firing |
| AOC DBLF-60SF | 600μm Scatter Free Side firing |
| AOC DBLF-60 | 600μm Free Beam |
| AOC Neos | Conical (conical shaped) |
| AOC Neos | Delta (wedge shaped) Handpiece, Laparoscopic and Bare Fiber |
| AOC HSD | Conical shaped with electrode |

## 5. Intended Use:

The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties:

- Urology
- Gynecology
- Gastroenterology
- Pulmonology
- General and Thoracic Surgery
- Neurosurgery (hemostasis)
- Ear, Nose, and Throat; Head/Neck Surgery
- Dermatology/Plastic Surgery

No new intended use was sought in this Premarket Notification.

The wavelength (980 nm) and tissue effects of the AOC Phase II 25 diode laser are closely matched to the predicate lasers at 805-830 and 980 nm. The 980 nm wavelength absorption in tissue is less dependent on variations in tissue pigment or vascularity than at 805 nm and has a slightly higher water absorption than the 1064 nm wavelength. Other predicate 980 nm diode laser systems have been found substantially equivalent to Nd:YAG and 805 nm diode lasers.

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# 6. Comparison of Technological Characteristics

The AOC Phase II 25 laser output is at the same nominal wavelength, 980 nanometers as the AOC 25, Cynosure Phototome, and Cytocare DioLase HP-1 lasers. Its laser tissue interactions would be expected to be identical. The same individual diode laser components are supplied by Applied Optronics for all four laser systems. The AOC Phase II 25 differs in wavelength from the DioMed 25, Indigo 830 and Sharplan 6020 (at 805 -830 nanometers) which has a slightly greater energy absorption in pigment and blood rich tissue. The 980 nm wavelength, like the Nd:YAG wavelength at 1064 nm, is less dependent on variations in tissue pigment and blood content.

The temporal output of all these systems is the same. These lasers are operated most often in the Continuous Wave (steady state) Mode but can be electronically gated to produce time pulses, single or repeated. The AOC Phase II 25 laser has a Continuous, Single Pulse, Countdown Pulse, Repeat Pulse, and Exponential Pulse output which are found on one or more of the predicate lasers. Its range of timed outputs are within the ranges of the above cleared products.

The output power of the AOC Phase II 25 is about the same as the power of the Diomed 25, Indigo 830, and Sharplan 6020. For applications using contact fibers with sculpted tips which typically operate below 25 watts, the difference in output is not clinically significant. The lower output power of the AOC Phase II 25 in comparison to the CytoCare and Cynosure 980 nm lasers can be compensated for by using smaller diameter fibers for equal power density or exposing target tissue for longer duration (equivalent energy).

The AOC Phase II 25 laser system has the same overall characteristics and features as the predicate diode laser systems. Like these lasers, the AOC Phase II 25 provides for adjustable power output, internal monitoring of power output accuracy, prominent power output display, operation in the Continuous Mode and Single Pulse, and other Modes (with adjustable pulse duration), foot switch activation, safety interlocks, a red aiming beam, Ready and Standby Modes, an electrically safe design, visual and audible indicators of operation, as well as a rugged cabinet designed for the clinical environment.

Like The Sharplan 6020, the AOC Phase II 25 is equipped for handswitch activation of the laser output for convenient surgical control. Also, like the Indigo unit, the AOC Phase II 25 has a Decay (e.g., exponential) Pulse mode.

# 7. Performance Data

No clinical test data was submitted in support of this submission. Peer reviewed clinical articles on the tissue interaction at 980 nm were included in the 510 (k). Bench test data was submitted demonstrating that the design is able to produce the rated power and wavelength.

Notice: This Summary was prepared in order to comply with CFR 21 807.87. AOC Medical Systems makes no claim that any disease or other condition can be cured and promotes its laser as a surgical tool only for use by qualified physicians. Laser surgery, like any surgery, entails necessary risks, some of which may result in complications, injury or, in the extreme, death.