(485 days)
Not Found
No
The 510(k) summary describes a standard CO2 surgical laser system with electromechanical controls and a touchscreen interface. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies listed are focused on electrical and laser safety standards, not AI/ML performance metrics.
Yes.
The device is used for surgical procedures like vaporization, excision, ablation, or photocoagulation of soft tissues, which are therapeutic interventions. Additionally, the description explicitly mentions its use in "Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment" standards.
No
The Aurora MD-30 CO2 Laser is described as a "surgical laser system" used for vaporization, excision, ablation, or photocoagulation of soft tissue in various surgical specialties. Its function is to perform medical procedures, not to diagnose conditions.
No
The device description clearly outlines a physical laser system with hardware components such as a laser source, articulated arm, fibers, optical switch, touchscreen, and console. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "vaporization, excision, ablation, or photocaogulation of soft tissue in the surgical specialties..." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical laser system that delivers energy to tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical intervention.
N/A
Intended Use / Indications for Use
The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, excision, ablation, or photocaogulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Aurora MD-30 CO2 Laser is a Carbon Dioxide (CO2) surgical laser system that can deliver up to 30 watts of laser power in the 11.2-micron range in the infrared. The laser can be used in a variety of surgical specialties. The power can be selectively delivered either through an articulated arm or through infrared fibers using an integrated electromechanically controlled optical switch that directs the beam either vertically into the articulated arm or at an angle into the fiber. The laser can operate in either continuous wave, pulsed or super pulse modes. It can deliver laser power down to 1/2 a watt and can operate down to millisecond pulse widths. The system also has a visible aiming beam to indicate where the CO2 laser beam will be delivered.
The laser system has a 12inch highly visible color touchscreen to control the laser. It consists of a small self-contained floor standing, easily moveable console which contains the laser and all associated electronics and delivery systems.
The Aurora MD-30 CO2 Laser has an integrated dual switch adapter that is operated by an electrical linear motor and controlled by the console. The switch allows the user to redirect the laser beam from the articulated arm to the fiber as desired.
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)
Non-Clinical Testing Summary:
IEC 60601-1:2005 Ed.3+A1;C1:2014 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - PASS
IEC 60601-1-6:2010Ed.3+A1 - Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability - PASS
IEC 60601-2-22:2019 Ed.4 - Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment - PASS
IEC 60601-1-2:2014Ed.4 - Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests - PASS
Clinical Testing:
NA - Clinical testing was not required to establish substantial equivalence
Key results: Performance testing conducted supports that the device can be used safety and effectively for the proposed indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, bold blue font.
September 22, 2022
Laser Engineering, Inc. Laurie Dobbs Quality Assurance 475 Metroplex Drive Suite 401 Nashville, Tennessee 37211
Re: K211605
Trade/Device Name: Dual Switch 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: May 20, 2021 Received: May 25, 2021
Dear Laurie Dobbs:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211605
Device Name Aurora MD-30 CO2 Laser
Indications for Use (Describe)
The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, excision, ablation, or photocaogulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Laser Engineering 510k
510(k) Summary
In accordance with 21 CFR 807.92 the 510(k) Summary for the Laser Engineering Aurora MD-30 CO2 Laser is provided below.
| Submitter: | Laser Engineering
475 Metroplex Drive, Suite 401
Nashville, TN 37211
Tel: (615) 739-5418 |
|----------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Laurie Dobbs
Management Representative
Email: 1.dobbs@americansurg.com |
| Date Prepared: | 8-22-2022 |
| Device Proprietary Name: | Aurora MD-30 CO2 Laser |
| Device Common Name: | Aurora MD-30 CO2 Laser |
| Classification Name: | Powered Laser Surgical Instrument |
| Classification Regulation: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Predicate Device Name(s): | MD CO2 Surgical Laser System
Dual Switch |
| Predicate Manufacturer: | Laser Engineering |
| Predicate 510k(s): | K905676, K951812 |
4
Device Description:
The Aurora MD-30 CO2 Laser is a Carbon Dioxide (CO2) surgical laser system that can deliver up to 30 watts of laser power in the 11.2-micron range in the infrared. The laser can be used in a variety of surgical specialties. The power can be selectively delivered either through an articulated arm or through infrared fibers using an integrated electromechanically controlled optical switch that directs the beam either vertically into the articulated arm or at an angle into the fiber. The laser can operate in either continuous wave, pulsed or super pulse modes. It can deliver laser power down to 1/2 a watt and can operate down to millisecond pulse widths. The system also has a visible aiming beam to indicate where the CO2 laser beam will be delivered.
The laser system has a 12inch highly visible color touchscreen to control the laser. It consists of a small self-contained floor standing, easily moveable console which contains the laser and all associated electronics and delivery systems.
The Aurora MD-30 CO2 Laser has an integrated dual switch adapter that is operated by an electrical linear motor and controlled by the console. The switch allows the user to redirect the laser beam from the articulated arm to the fiber as desired.
Indications for Use:
The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, excision, ablation, or photocoagulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
Technological Characteristics Compared to Predicate Device
| Product | Ultrapulse
Laser | MD CO2
Laser & Dual
Switch | Aurora MD-
30 CO2 laser | |
|--------------------------|----------------------|----------------------------------|------------------------------|---------|
| 510(K)
Number | K951812 | K905676 | K211605 | |
| Manufacturer | Coherent
/Lumenis | Laser
Engineering,
Inc | Laser
Engineering,
Inc | |
| Laser Type | CO2 Gas
Laser | CO2 Gas
Laser | CO2 Gas
Laser | Same |
| Operating
Wavelengths | 11.1
Microns | 10.6 Microns | 11.2 Microns | Similar |
| Output
Power | 0.5 to 45
Watts | 0.5 to 30
Watts | 0.5 to 30
Watts | Similar |
| Laser Beam
Mode | TEM00 | TEM00 | TEM00 | Same |
5
| Operating
Modes | Continuous
or Pulsed | Continuous
or Pulsed | Continuous
or Pulsed | Same |
|-----------------------------------|--------------------------------|----------------------------------------------|----------------------------------------------|--------------|
| Pulse Widths | 0.01 to 1.0
Sec | 0.05 to 1.0
Sec | 0.05 to 1.0
Sec | Same/Similar |
| Control
method | Computer
and
Touchscreen | Computer
and
Touchscreen | Computer
and
Touchscreen | Same |
| Aiming Beam
Power | 5 Milliwatts | 5 Milliwatts | 5 Milliwatts | Same |
| Laser Power
Delivery
System | Articulated
arm | Articulated
arm or
Hollow
Waveguide | Articulated
arm or
Hollow
Waveguide | Same/Similar |
| Beam
Switching
Method | n/a | Manual
Switch | Electro-
mechanical
Linear Motor | Different |
| Output
Indicator | LEDs | LEDs | LEDs | Same |
The proposed device's output parameters are either the same or similar as output parameters from the predicate devices. The proposed device uses an electro-mechanical motor rather than a manual switch to divert the output beam. This modification does not raise new types of questions regarding the safety and efficacy of the device, and the proposed device's beam diverter has been tested to demonstrate that it can be used safely and effectively for the proposed indications for use.
6
Non-Clinical Testing Summary
| Test Standard | Test Description | Test Report | Test Results |
|---|---|---|---|
| IEC 60601-1:2005 | |||
| Ed.3+A1;C1:2014 | Medical Electrical Equipment - Part 1: | ||
| General Requirements For Basic | |||
| Safety And Essential Performance | 104954641BOX- | ||
| 002 | PASS | ||
| IEC 60601-1- | |||
| 6:2010Ed.3+A1 | Medical Electrical Equipment - Part 1- | ||
| 6: General Requirements For Basic | |||
| Safety And Essential Performance - | |||
| Collateral Standard: Usability | 104954641BOX- | ||
| 003 | PASS | ||
| IEC 60601-2- | |||
| 22:2019 Ed.4 | Medical Electrical Equipment - Part 2- | ||
| 22: Particular Requirements for Basic | |||
| Safety and Essential Performance of | |||
| Surgical, Cosmetic, Therapeutic and | |||
| Diagnostic Laser Equipment | 104954641BOX- | ||
| 004 | PASS | ||
| IEC 60601-1- | |||
| 2:2014Ed.4 | Medical Electrical Equipment - Part 1- | ||
| 2: General Requirements For Safety - | |||
| Collateral Standard: Electromagnetic | |||
| Compatibility - Requirements And | |||
| Tests | 104954641BOX- | ||
| 017 | PASS |
Clinical Testing:
NA - Clinical testing was not required to establish substantial equivalence
Conclusions:
The proposed device utilizes technological characteristics that are the same or are similar to the predicate devices. The proposed device's technological characteristics do not raise new types of questions regarding safety and effectiveness, and performance testing conducted supports that the device can be used safety and effectively for the proposed indications for use above. Based on the comparison and analysis of data within this 510(k) submission, the proposed device is considered to be Substantially Equivalent (SE) to the predicate devices.