MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM

K960475 · Luxar Corp. · GEX · Apr 26, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960475
• Device Name: MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
• Applicant: Luxar Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of: - Gynecology - Laparoscopic Surgery including GYN laparoscopy - Dermatology - Dental and oral surgery - Orthopedic - General Surgery - Otorhinolaryngology - Podiatry

Device Story

The Luxar modified LX-20 CO2 Surgical Laser System generates infrared laser energy at 10.6 microns. Energy is delivered to soft tissue via a knuckled beam delivery assembly, hollow fiber waveguides, handpieces, and sterile delivery tips. The system is used by surgeons in clinical settings (e.g., OR, clinic) for soft tissue surgical procedures. The modified version introduces an accessory patterning handpiece, associated cabling, and control software/electronics to the existing LX-20 platform. The device is operated by physicians; the laser output allows for precise tissue interaction, aiding in surgical outcomes by facilitating controlled tissue removal or coagulation.

Clinical Evidence

No clinical data were presented.

Technological Characteristics

CO2 laser system; 10.6 micron wavelength; RF excited lasing tube; microprocessor-controlled; includes accessory patterning handpiece, cabling, and control electronics. Delivery via knuckled beam assembly, hollow fiber waveguides, and sterile tips. Three base console configurations (LX-20i, LX-20SP, LX-20LP).

Indications for Use

Indicated for vaporization, incision, excision, ablation, or photocoagulation of soft tissue in patients undergoing procedures in gynecology, laparoscopic surgery (including GYN), dermatology, dental/oral surgery, orthopedics, general surgery, otorhinolaryngology, and podiatry.

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

• Luxar LX-20 C02 Surgical Laser System (K953074)

Submission Summary (Full Text)

{0}

LUXAR
CORPORATION
K960475
APR 26 1996

# 12.0 510(K) SUMMARY

Page 1 of 2

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. Submitter's name, address, telephone, fax, & contact person

Luxar Corporation

19204 N Creek Parkway Bothell, Wa. 98011

Phone: [phone] Fax: [phone]

Phillip Burwell, Product Assurance Manager

2. Date summary prepared:

January 30, 1996

3. Product trade or proprietary name:

Luxar modified LX-20 C02 Surgical Laser System

4. Product common name:

C02 Laser

5. Product classification name

21C.F.R. § 878.4810 Lasers in general and plastic surgery and in dermatology

21C.F.R. § 874.4500 Lasers for use in ENT

21C.F.R. § 884.4550 Gynecologic surgical laser

6. Legally marketed predicate device used for equivalency:

Luxar LX-20 C02 Surgical Laser System (K953074)

7. Description:

The Luxar modified LX-20 surgical laser system produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, hollow fiber waveguides, handpieces, and sterile delivery tips.

Modified LX-20 Laser system 510(k) submission Page 65
1/31/96
510KSCN3.DOC
19204 NORTH CREEK PKWY. • BOTHELL, WA 98011-8009
[phone] FAX [phone]

{1}

LUXAR
CORPORATION

Page 2 of 2

8. Statement of intended use:

The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:

- Gynecology
- Laparoscopic Surgery including GYN laparoscopy
- Dermatology
- Dental and oral surgery
- Orthopedic
- General Surgery
- Otorhinolaryngology
- Podiatry

No new indications were sought in the premarket notification and no clinical data were presented.

9. Technological characteristics:

The laser output characteristics of the modified LX-20 system and the cleared LX-20 system are identical in average power, increments of power available, and wavelength. The modified LX-20 and the cleared LX-20 share the same RF excited lasing tube, delivery system construction, main chassis, power supply, safety systems, microprocessor controller, and much of the same electronics. The modified LX-20 laser system maintains the same 3 base consoles established pursuant to the predicate K953074 - namely the LX-20i, the LX-20SP, and the LX-20LP. The technological characteristics of the modified LX-20 that are different from the predicate LX-20 are as follows:

The modified unit adds an accessory patterning handpiece and related tip, cabling, and control software and electronics.

Luxar believes that the minor differences in the delivery capabilities of the modified LX-20 and the LX-20 do not raise any new issues of safety and effectiveness.

Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients or operators due to operator error or in high risk procedures.

Modified LX-20 Laser system 510(k) submission Page 66 1/31/96 510KSCN3.DOC
19204 NORTH CREEK PKWY. • BOTHELL, WA 98011-8009
[phone] FAX: [phone]