(62 days)
Luxar LX-20SP, DEKA SmartXide CO2 Laser Systems
Not Found
No
The device description and performance studies focus on the laser technology and its physical parameters, with no mention of AI or ML algorithms for control, analysis, or other functions.
No
The device is used for surgical procedures such as incision, excision, vaporization, ablation, and coagulation of soft tissue, which aims to alter tissue rather than restore health.
No
The device is described as a CO2 laser system intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue, not for diagnosis.
No
The device description clearly outlines hardware components including a laser tube, fiber waveguide, handpiece assembly, and touch-screen display panel. The performance studies also reference verification and validation tests per product requirements and specifications, and inspections and tests derived from applicable regulations and safety standards, which are typical for hardware medical devices.
Based on the provided information, the LightScalpel LS-10 CO2 Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue." This describes a surgical tool used directly on a patient's body for treatment.
- Device Description: The description details a laser system that delivers energy to tissue. This is consistent with a surgical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVD devices are specifically designed for these purposes.
Therefore, the LightScalpel LS-10 CO2 Laser System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.
Product codes
GEX
Device Description
The LightScalpel LS-10 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO₂) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.
A "calibration port" on the side of the laser system allows checking and setting the power emitted from the distal laser aperture and serves as a check on fiber waveguide transmission efficiency.
The laser system has safety features complying with requirements in 21 CFR 1040, Performance Standards for Light Emitting Products; IEC 60601-2-22, Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ; and IEC 60825-1, Safety of laser products –Part 1: Equipment classification and requirements. Major safety features are as follows:
System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling.
The laser system, components, and features are illustrated in Figure 1. Laser system physical characteristics are:
Dimensions: 34" H x 15" W x 15" D
Weight (Pounds / Kg): ~ 35 / ~ 16
Electrical Power: 115 VAC, 7.5 A, 50/60 Hz
Delivery System: Flexible Fiber Waveguide; ~ 0.7mm ID.; Handpiece w/internal focusing lens.
Purge Gas: Internal air pump purge through the Fiber and Handpiece.
System Cooling: Air; two thermostatically controlled fans with over-temperature protection.
Mobility: 4 wheels and handgrip on console for convenient system positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LightScalpel LS-10 CO2 Laser System has been evaluated for performance equivalent to predicate devices through a combination of (1) verification and validation tests per product requirements and specifications and (2) inspections and tests derived from applicable regulations and safety standards as noted below.
- 21 CFR 1040, Performance Standards for Light-emitting Products
- IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-22. Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1, Safety of laser products Part 1: Equipment classification, requirements and user's guide
Device performance evaluation did not involve Animal of Clinical Testing.
A comparison between the LS-10 and the predicated carbon dioxide lasers showed that these devices have similar laser characteristics and output parameters and therefore a determination of equivalence can be made between the predicate devices and the LS-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Luxar LX-20SP, DEKA SmartXide CO2 Laser Systems
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K123037 1/4
Image /page/0/Picture/1 description: The image contains the words "light" and "Scalpel". The word "light" is in bold font and is connected to the letter "S" in "Scalpel" by a curved line. There is a star-like symbol below the word "light" and a horizontal line at the bottom of the image.
LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville. WA 98072 PH: 425-368-1588 FAX: 425-483-6015
SECTION 5 - 510(k) Summary
NOV 2 9 2012
510(k) Summary Preparation Date:
-
- 510(K) Owner:
Light Scalpel LLC 16932 Woodinville-Redmond Road NE, Suite 206 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-483-6015 (FAX)
- 510(K) Owner:
-
- 510(k) Contact:
David Walters General Manager 16932 Woodinville-Redmond Road NE, Suite 206 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-483-6015 (FAX) dwalters@lightscalpel.com
- 510(k) Contact:
-
- Device Trade Name: LightScalpel LS-10
Common Name: CO2 Laser System
- Device Trade Name: LightScalpel LS-10
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810).
"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."
Classification: Class II
Product Code: GEX
-
- Predicate Device(s)
The LightScalpel CO2 Laser System is equivalent in operating principles and intended uses to the Luxar LX-20SP and DEKA SmartXide CO2 Laser Systems.
- Predicate Device(s)
-
- Device Description and Function
The LightScalpel LS-10 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO₂) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.
- Device Description and Function
1
12 3037 2/4
Image /page/1/Picture/1 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the "S" in "Scalpel" is stylized as a curved line that extends from the bottom left of the image, where it is depicted as a starburst. The rest of the word "Scalpel" is in a regular font.
LightScalpel LLC 16932 Woodinville-Redmond Rd NE, Suite 206 Woodinville, WA 98072 PH: 425-368-1588 FAX: 425-483-6015
A "calibration port" on the side of the laser system allows checking and setting the power emitted from the distal laser aperture and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below:
| Parameter | LightScalpel LS-10 |
|---|---|
| CW Power (watts) | 2 - 10 |
| Pulsed Power (watts) | 2 - 10 |
| Gated Pulse Width (msec) | 5 - 500 |
| Gated Rep Rate (pps) | 1 or 2 - 20 |
| Single Pulse Energy (mJ) | 10 - 5000 |
| Superpulse Power (watts-avg.) | 2 - 5 |
| Gated Pulse Widths (msec) | 10 - 500 |
| Superpulse Pulse Rates (pps) | 160 - 375 |
| Gated Rep Rate (pps) | 1 or 2 - 30 |
| Superpulse Peak Power (watts) | 30 |
| Superpulse Pulse Width (usec) | 100 - 800 |
The laser system has safety features complying with requirements in 21 CFR 1040, Performance Standards for Light Emitting Products; IEC 60601-2-22, Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ; and IEC 60825-1, Safety of laser products –Part 1: Equipment classification and requirements. Major safety features are as follows:
System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling.
The laser system, components, and features are illustrated in Figure 1. Laser system physical characteristics are:
2