(219 days)
Not Found
No
The summary describes a standard CO2 laser system with microprocessor control, but there is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The device is described as performing medical functions like "coagulation, vaporization, ablation or cutting of soft tissue" in various surgical fields, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that it is used for surgical procedures like coagulation, vaporization, ablation, and cutting of soft tissue. It does not mention any diagnostic functions or the collection/analysis of data for diagnostic purposes.
No
The device description explicitly states it is a "CO2 laser system" with a "sealed CO2 laser tube," "articulated arm beam delivery system," and "attachable laser accessories," all of which are hardware components.
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 device used for surgical procedures on soft tissue (coagulation, vaporization, ablation, cutting). This is a therapeutic or surgical device, not a diagnostic one.
- Device Description: The description details a CO2 laser system used for delivering energy to tissue. This aligns with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue.
N/A
Intended Use / Indications for Use
The LS Family of CO2 Lasers are intended to be used for Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
Product codes
GEX
Device Description
The LS Family of CO2 Lasers are microprocessor-controlled CO2 laser systems using a sealed CO2 laser tube providing either 15 watts maximum power (LS-15 ) or 25 watts maximum power (LS-25). The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
UltraPulse CO2 Surgical Laser K030147, Luxar LX-20SP Surgical Laser K953074
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
Attachment I 510(K) Summary LS Fsmily of CO2 Lasers
0C7 8 - 2004
KO40563
This 510(K) Summary of safety and effectiveness for the LS-15 and LS-25 CO2 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 |
|---|---|
| Address: | Sandstone Medical Technologies LLC |
| 516 Scott Street | |
| Homewood, AL 35209 USA | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | September 22, 2001 |
| Device Trade Name: | LS Family of CO2 Lasers including : |
| LS-15 CO2 Laser System | |
| LS-25 CO2 Laser System | |
| Common Name: | CO2 Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | UltraPulse CO2 Surgical Laser K030147 |
| Luxar LX-20SP Surgical Laser K953074 | |
| Description of the LS Family of CO2 | |
| Lasers: | The LS Family of CO2 Lasers are microprocessor-controlled |
| CO2 laser systems using a sealed CO2 laser tube providing either | |
| 15 watts maximum power (LS-15 ) or 25 watts maximum power | |
| (LS-25). The system incorporates a CO2 laser tube within the | |
| main cabinet, an articulated arm beam delivery system and | |
| attachable laser accessories. The unit is activated for laser | |
| emission by a footswitch. | |
| Intended use of the LS Family of CO2 | |
| Lasers: | The LS Family of CO2 Lasers are intended to be used |
| for | |
| Coagulation, vaporization, ablation or cutting of soft tissue in | |
| dermatology and plastic surgery, general surgery, podiatry and | |
| otorhinolaryngology. | |
| Performance Data: | None |
| Results of Clinical Study: | None |
| Conclusion: | The LS Family of CO2 Lasere are substantially equivalent to |
| other existing CO2 Laser System in commercial distribution for | |
| use in Dermatology and Plastic Surgery. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sandstone Medical Technologies, LLC c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K040563
Trade/Device Name: Sandstone Medical Technologies LLC Family of LS CO2 Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 5, 2004 Received: July 12, 2004
OCT 8 - 2004
Dear Ms. Hoy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booteermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the energy, 1976, the enactment date of the Medical Device Amendments, or to conimer or prior to may 2011 accordance with the provisions of the Federal Food, Drug, de noos that have been require approval of a premarket approval application (PMA). and Cosmeter Fee (110) has the device, subject to the general controls provisions of the Act. The r ou may, atores provisions of the Act include requirements for annual registration, listing of general controls providers practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de roo as onable 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 mcan r tease of a 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Connie White Hoy
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin manteening of substantial equivalence of your device to a legally premarket notification. The PDF intellig of cation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Computarse in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KO40263 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Sandstone Medical Technologies LLC Family of LS CO2 Lasers Device Name:
Indications For Use:
Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
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)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K040563 |
|---|---|
| --------------- | --------- |
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