(85 days)
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No
The summary describes a surgical laser system and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is used for surgical procedures like vaporization, incision, excision, ablation, or photocoagulation of soft tissue, which are therapeutic interventions.
No
The document describes the device's intended use as the "vaporization, incision, excision, ablation, or photocoagulation of soft tissue," which are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description explicitly states it is a "surgical laser system" that produces laser energy and directs it through hardware components like a beam delivery assembly, waveguides, handpieces, and tips. This indicates it is a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on soft tissue (vaporization, incision, excision, ablation, photocoagulation). This is a therapeutic or surgical device, not a diagnostic one.
- Device Description: The device description details a surgical laser system that delivers energy to tissue. This aligns with a surgical device, not an IVD which would typically involve analyzing samples (blood, urine, tissue, etc.) outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information based on in vitro analysis.
Therefore, the Luxar modified LX-20 surgical laser system is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for LUXAR Corporation. The logo is in black and white and features a bold, sans-serif font. The word "LUXAR" is in large letters, with the word "CORPORATION" in smaller letters below.
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.
- Submitter's name, address, telephone, fax, & contact person 1. Luxar Corporation 19204 N Creek Parkway Bothell, Wa. 98011 Phone: 206-483-4142 Fax: 206-483-6844 Phillip Burwell, Product Assurance Manager
- Date summary prepared: 2. January 30, 1996
- Product trade or propietary name: 3. Luxar modified LX-20 C02 Surgical Laser System
-
- Product common name: C02 Laser
- న్. 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
- Legally marketed predicate device used for equivalency: 6. Luxar LX-20 C02 Surgical Laser System (K953074)
-
- 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.
1
Image /page/1/Picture/0 description: The image shows the logo for LUXAR CORPORATION. The word "LUXAR" is in large, bold, sans-serif font, with the "U" having a distinctive curved top. Below "LUXAR", in a smaller font size, is the word "CORPORATION", with each letter spaced apart. The logo has a textured, slightly distressed appearance.
Page 2 of 2
-
- 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:
- Statement of intended use:
-
· 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 (206) 483-4142 FAX: (206) 483-6844