(93 days)
Not Found
No
The summary describes a laser system for soft tissue treatment and does not mention any AI or ML components or functionalities.
No
The device is used for surgical procedures like coagulation, vaporization, ablation, and cutting of soft tissue, which are not therapeutic in nature.
No
The document describes the device's function as being for coagulation, vaporization, ablation, or cutting of soft tissue, primarily for treatment purposes. There is no mention of the device being used to identify, measure, or predict any medical condition or anatomical feature.
No
The device description clearly outlines a physical console, articulated arm, handpiece, and footswitch, indicating it is a hardware-based laser system, 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 the device as a surgical laser system used for procedures like coagulation, vaporization, ablation, and cutting of soft tissue. These are direct treatments performed on the patient's body.
- Device Description: The description details a physical laser system with handpieces and controls, designed for delivering laser energy to tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a therapeutic device used for surgical procedures.
N/A
Intended Use / Indications for Use
The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. There is an additional Er: YAG handpiece that attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (including skin)
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)
Performance Data: None
Results of Clinical Study: None
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.
LS-40 CO2 Laser System (K)093793, MLT Erbium:YAG Laser System (K)032599
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.
0
Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System
K110897
JUL - 1 2011
This 510(K) Summary of safety and effectiveness for the Cortex CO2 / Er:YAG Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Sandstone Medical Technologies, LLC | | Sandstone Medical
Technologies LLC Cortex
CO2 / Er:YAG-Laser System | Sandstone Medical
Technologies LLC CO2 Laser
(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Address: | 105 Citation Court
Birmingham, AL 35209 | Laser type | Sealed-off CO2 laser tube | Sealed-off CO2 laser tube |
| Contact Person: | Mark Rohrer | Wavelength | 10.6 micron (10,600nm) | 10.6 micron (10,600nm) |
| Telephone:
Email: | 205-290-8251 - phone
ssmed@bellsouth.net | Power to tissue | 0.5 -40 W | 0.5 -40 W |
| Preparation Date: | March 19, 2011 | Super pulse peak
power | 500W | 500W |
| Device Trade Name: | Cortex CO2 / Er:YAG Laser System | Laser operation
modes | CW, Super pulse | CW, Super pulse |
| Common Name: | CO2 Laser
Er:YAG Laser | Tissue exposure
modes | Continuous, Single Pulse,
Repeat Pulse | Continuous, Single Pulse,
Repeat Pulse |
| Classification Name: | Instrument, Surgical, Powered, laser
79-GEX, 21 CFR 878-48 | Aiming beam | 3mW (650nm diode)
adjustable | 3mW (650nm diode)
adjustable |
| Legally Marketed Predicate
Device: | LS-40 CO2 Laser System (K)093793
MLT Erbium:YAG Laser System (K)032599 | Articulated arm | 7-joint articulated arm | 7-joint articulated arm |
| Description of the Cortex
CO2/Er:YAG Laser System | The Cortex system and controls are contained in a single
console. Electrical power is supplied to the console by the
facility's power source. The CO2 laser is delivered via an
articulated arm that is permanently attached to the console.
There is an additional Er: YAG handpiece that attaches to a
port on the console and contains the laser cavity in the head
of the handpiece. The user interface is a touch screen
located on the console. The user activates the laser
emission by means of a footswitch. | Working radius | 130cm | 130cm |
| Intended use of the Cortex
CO2 / Er:YAG Laser System | The CO2 laser is indicated for coagulation, vaporization,
ablation or cutting of soft tissue in dermatology and plastic
surgery, general surgery, podiatry and otorhinolaryngology. | Cooling type | Closed loop liquid | Closed loop liquid |
| | The Er:YAG handpiece is designed specifically for
superficial skin ablation resulting in skin dermabrasion, and
the treatment of wrinkles. In addition this system is intended
for coagulation, vaporization, ablation, or cutting of soft
tissue (skin) in dermatology, plastic surgery (including
aesthetic surgery). | Power input
requirements | 110VAC/60Hz or
220VAC/50Hz +/- 10% | 110VAC/60Hz or
220VAC/50Hz +/- 10% |
| Dimension (Wide) | 34cm | 34cm | | |
| (Depth) | 46cm | 46cm | | |
| (Height) | 96cm | 96cm | | |
1
Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System
Performance Data: None
. ..
Results of Clinical Study: None
Summary of Technological Characteristics:
Technical Specifications Comparison for the CO2 Laser (including console specification)
.
2
Attachment 5 510(K) Summary Cortex CO2 / Er:YAG Laser System
Technical Specifications Comparison for the ER:YAG Laser Handpiece
し
...
| | Sandstone Medical
Technologies LLC
Cortex CO2 / Er:YAG
Laser System | Sandstone Medical
Technologies LLC
Er:YAG Laser
(Predicate) |
|-----------------|------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 8 J/cm2 | 8 J/cm2 |
| Pulse Width | 300 µs | 300 µs |
| Repetition Rate | Up to 10 pulse per second | Up to 10 pulse per second |
| Spot Size | 1.5mm, 3mm, 6mm,
9mm | 1.5mm, 3mm, 6mm,
9mm |
| Conclusion: | The Cortex CO2 / Er:YAG Laser System is
comparable to the predicate device in terms of
indications for use, technical specifications, operating
performance features, general design. |
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer Managing Member 105 Citation Court Homewood, Alabama 35209
JUL - 1 2011
Re: K110897
Trade/Device Name: Cortex Co2/Er: Y AG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and in plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 18, 2011 Received: May 24, 2011 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 、
Dear Mr. Rohrer:
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. Ilsting 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
4
Page 2 - Mr. Mark Rohrer
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 (reporting of medical 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/CDRH/CDRHOffices/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 tollofre and (800) 638-2041 or (301) 796-7100 or at its Internet address
-http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
to
Jk.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Cortex Co2 / Er:YAG Laser System
The CO2 laser is indicated for coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
The Er: YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel RPO Page 1 of 1
(Division Sign Off) mkn
(Division Sign-6 Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110897