(103 days)
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the description focuses on microprocessor control and scanned energy delivery, not AI/ML-driven analysis or decision-making.
Yes
The device is used to deliver laser light for skin resurfacing, which directly treats a condition (skin imperfections).
No
The device is described as a scanning handpiece used to deliver laser light for skin resurfacing, which is a treatment modality, not a diagnostic one. While histology was collected to determine depth of penetration, this seems to be a performance study aspect rather than the primary intended use of the device itself for diagnosis.
No
The device description explicitly states it is a "scanning handpiece" and a "microprocessor-controlled laser system," indicating the presence of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver laser light to the skin for resurfacing. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a handpiece that delivers laser energy to tissue. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to diagnose a condition or provide information about a patient's health status.
- Anatomical Site: The anatomical site is the "targeted area for skin resurfacing," which is a part of the patient's body.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic purposes. This device's function is to deliver energy for treatment, not to analyze samples for diagnosis.
N/A
Intended Use / Indications for Use
The scanning handpiece is intended to be used as an accessory to the LS Family of CO2 Lasers to deliver the laser light to the targeted area for skin resurfacing in a fractionated manner.
Product codes
GEX
Device Description
The LS Family of CO2 lasers are microprocessor-controlled laser systems that incorporate a handpiece to deliver energy to the tissue in a scanned, fractionated pattern.
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
Prescription Use
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
Histology was collected from a small sample of patients to determine the depth of penetration.
Key Metrics
Not Found
Predicate Device(s)
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 III 510(K) Summary LS Family of CO2 Lasers with Fractionated Handpiece
082101
This 510(K) Summary of safety and effectiveness for the LS Family of CO2 Lasers is submitted in accordance with the requirements of the SMDA 1990 and the following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Sandstone Medical Technologies, LLC |
|---|---|
| Address: | Sandstone Medical Technologies, LLC |
| 105 Citation Court | |
| Homewood, Alabama 35209 | |
| Contact Person: | Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | July 20, 2008 |
| Device Trade Name: | LS Family of CO2 Lasers |
| Common Name: | CO2 Laser |
| Classification Name: | Instrument, Surgical, Powered, laser 79-GEX, |
| 21 CFR 878-48 | |
| Equivalent Device: | LS Family of CO2 Lasers cleared under K040563 |
| Description of the LS Family System: | The LS Family of CO2 lasers are microprocessor- |
| controlled laser systems that incorporate a handpiece to | |
| deliver energy to the tissue in a scanned, fractionated | |
| pattern. | |
| Intended Use: | The scanning handpiece is intended to be used as an |
| accessory to the LS Family of CO2 Lasers to deliver the | |
| laser light to the targeted area for skin resurfacing in a | |
| fractionated manner. | |
| Performance Data: | None |
| Results of Clinical Study: | Histology was collected from a small sample of patients |
| to determine the depth of penetration. | |
| Conclusion: | The LS Family of CO2 Lasers with the additional |
| scanning handpiece is substantially equivalent to the | |
| previously cleared LS Family of CO2 Lasers. |
1
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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer Managing Member 105 Citation Court Homewood. Alabama 35209
NOV - 5 2008
Re: K082101
Trade/Device Name: Sandstone Medical Technologies Family of LS CO2 Lasers with Scanning Handpiece 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: September 24, 2008 Received: September 29, 2008
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, listing of devices, good manufacturing 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 may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 - Mr. Mark Rohrer
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KO82101 510(k) Number (if known): K Pending
Device Name:
Sandstone Medical Technologies Family of LS CO2 Lasers with Scanning Handpiece
Skin Resurfacing
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 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)
YlilkRPOde Cir mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082101