(118 days)
Not Found
No
The summary describes a standard CO2 laser system with adjustable power and emission modes controlled by operator input. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on safety and performance standards for laser equipment, not AI/ML model validation.
Yes
The device is described as a CO2 Laser System intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization, which are therapeutic medical interventions. Furthermore, its performance studies refer to "therapeutic and diagnostic laser equipment" (IEC 60601-2-22).
No
The device is a CO2 laser system intended for surgical procedures, not for diagnostic purposes. Its functions include incision, excision, vaporization, and coagulation.
No
The device description clearly outlines hardware components including a laser tube, fiber waveguide, handpiece, and touch-screen display panel, indicating it is a physical medical 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 a surgical laser system used for procedures like incision, excision, vaporization, etc., directly on the patient's tissue. This is a therapeutic and surgical device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a laser system that delivers energy to tissue via a fiber waveguide and handpiece. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Clinicon SureLase CO2 Laser System is a surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology.
Product codes
GEX
Device Description
The Clinicon SureLase 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 20 Watts Continuous Wave (CVV). Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece / tip 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 SureLase 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Image /page/0/Picture/0 description: The image shows the word "CLINICON" in a bold, sans-serif font. To the left of the word is a logo consisting of several geometric shapes, including triangles and parallelograms, arranged to form a stylized design. The overall impression is that of a company logo or brand name, possibly related to the medical or healthcare industry given the name "CLINICON".
Clinicon Corporation 3025 Industry Street Suite A Oceanside, CA 92054 760-439-1700 760-439-1798 (FAX)
SION FOCUSED"
SECTION 5 - 510(k) Summary
510(k) Summary Preparation Date:
-
- 510(K) Owner:
Fritz A. Brauer, President Clinicon Corporation 3025 Industry Street Suite A Oceanside, CA 92054 800-254-6426 / 760-439-1700 / 760-439-1798 (FAX)
- 510(K) Owner:
-
- 510(k) Contact:
Gerald S. Palecki Quality / Regulatory Consultant Palecki Enterprises LLP 1107 259th ST NW Stanwood, WA 98292 760-715-5954 gpalecki@palecki-enterprises.com
- 510(k) Contact:
-
- Device Trade Name: SureLase
Common Name: CO2 Laser System
- Device Trade Name: SureLase
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 SureLase 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 Clinicon SureLase 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 20 Watts Continuous Wave (CVV). Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece / tip 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
SEP 25 2012
1
SECTION 5 - 510(k) Summary
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 | SureLase |
|---|---|
| CW Power (watts) | 2-20 |
| Pulsed Power (watts) | 2-20 |
| Gated Pulse Width (msec) | 5-500 |
| Gated Rep Rate (pps) | 1 or 2-20 |
| Superpulse Power (watts) | 2-10 |
| Gated Pulse Widths (msec) | 10-500 |
| Superpulse Pulse Rates (pps) | 160-375 |
| Gated Rep Rate (pps) | 1 or 2-30 |
| Peak Power (watts) | > 50 |
| 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:
| Parameter | SureLase |
|---|---|
| Dimensions | 40" H x 15" W x 15" D |
| Weight (Pounds / Kg) | ~ 47 / ~ 21.3 |
| Electrical Power | 115 VAC, 15 A, 50/60 Hz |
3
2
Delivery System: Flexible Fiber Waveguide; ~ 0.5mm ID.; Handpiece w/collet grip; wavequide tips.
- Purge Gas: Provision for external air or inert gas purge through the Fiber and Handpiece / Tip.
System Cooling: Air; two thermostatically controlled fans with over-temperature protection.
Mobility: 4 wheels and handgrip on console for convenient system positioning.
- Intended use(s) of the Device
The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization of soft tissue in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology
-
- Technological Characteristics Comparison to Predicate Devices
The technological characteristics comparison to predicate devices is summarized in the following table.
- Technological Characteristics Comparison to Predicate Devices
| Characteristic | Clinicon Surelase | Luxar LX-20 SP | DEKA SmartXide |
|---|---|---|---|
| Predicate 510(k) | N/A | K953074 | K072159 |
| Laser Medium | CO2 | CO2 | CO2 |
| Wavelength (µm) | 10.6 | 10.6 | 10.6 |
| Laser Drive Source | RF | RF | DC |
| Output Power (W) | 2 - 20 | 2 - 20 | 2 - 30 |
| Pulsed Power (W) | 2 - 20 | 2 - 20 | 0.5 - 15 |
| Gated PW (ms) | 5 - 500 | 5 - 500 | 0.2 - 80 |
| Gated Rep. Rate (pps) | 1 or 2 - 20 | 2 - 20 | 5 - 100 |
| Super Pulse (W) | 2 - 10 | 2 - 10 | 0.5 - 10 |
| Super Pulse Peak (W) | > 50 | 50 | 320 |
| Beam Delivery System | Flexible Fiber | ||
| Waveguide | Articulated Arm or | ||
| Flexible Fiber | |||
| Waveguide | Articulated Arm | ||
| System HxWxD (in) | 40 x 15 x 15 | 36 x 14 x 14 | 47 x 19 x 22 |
3
SECTION 5 - 510(k) Summary
| System Weight (lb) | 47 | 42 | 66 |
|---|---|---|---|
| Mobility | 4 Wheels & Handle | 4 Wheels & Handle | 4 Wheels & Handle |
| Electrical Power | 115 VAC | 115 VAC | 115 VAC |
| Intended Use | Incision, Excision, | ||
| Vaporization, | |||
| Ablation, | |||
| Coagulation, or | |||
| Cauterization of | |||
| Soft Tissue | Incision, Excision, | ||
| Vaporization, | |||
| Ablation, | |||
| Coagulation, or | |||
| Cauterization of | |||
| Soft Tissue | Incision, Excision, | ||
| Vaporization, | |||
| Ablation, | |||
| Coagulation, or | |||
| Cauterization of | |||
| Soft Tissue |
8. Performance Testing
The SureLase 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
9. Animal and Clinical Testing
Device performance evaluation did not involve Animal of Clinical Testing.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Clinicon Corporation % Palecki Enterprise, LLP Mr. Gerald S. Palecki Quality/Regulatory Consultant 1107 259TH Street NW Stanwood, Washington 98292
SEP 25 2012
Re: K121580
Trade/Device Name: SureLase CO2 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 8, 2012 Received: August 14, 2012
Dear Mr. Palecki:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
5
Page 2 - Mr. Gerald S. Palecki
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4 - Indications for Use
510(k) Number (if known): J/ (21580 Device Name: SureLase CO2 Laser System Indications for Use:
The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sian-Off
Office of Surgical, Orthopedic, and Restorative Device
510(k) K121580