(64 days)
Not Found
No
The summary describes a laser system for dermatological procedures with no mention of AI or ML capabilities.
Yes
The device is used for medical treatments such as skin ablation, treatment of wrinkles, removal of tattoos and pigmented lesions, and treatment of vascular lesions. These are all therapeutic applications.
No
The device description focuses on therapeutic applications like skin ablation, wrinkle treatment, coagulation, vaporization, tattoo removal, and treatment of vascular and pigmented lesions. There is no mention of its use for diagnosing medical conditions or diseases.
No
The device description clearly outlines a physical console, handpieces (Er:YAG and Nd:YAG lasers), and a footswitch, indicating it is a hardware-based medical device with potential software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The provided description clearly states that this device is a laser system used for treating conditions on the skin (ablation, dermabrasion, wrinkle treatment, tattoo removal, vascular lesions, pigmented lesions, hair removal). It directly interacts with the patient's body for therapeutic or aesthetic purposes.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the patient. The device applies energy directly to the skin.
- Intended Use: The intended use is focused on treating conditions, not diagnosing them based on laboratory analysis of specimens.
Therefore, based on the provided information, this device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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).
The Nd:YAG handpiece is indicated for:
- At the 1064nm wavelength dark ink tattoo removal, . removal of pigmented lesions and the removal or lightening of hair.
- At the 532nm wavelength removal of red ink . tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er:YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy is a wavelength of 2940nm. This handpiece can be removed and replaced with a q-switch Nd:YAG handpeice emitting wavelengths of 1064nm and 532nm laser energy can be added. 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
Skin, soft tissue, facial and leg veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
None
Description of the test set, sample size, data source, and annotation protocol
None
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None Performance Data:
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.
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
N/A
0
Attachment 5 510(K) Summary Triplex Er:YAG / Nd:YAG Laser System
APR 2 7 2011
This 510(K) Summary of safety and effectiveness for the Triplex Er:YAG / Nd: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 |
|---|---|
| Address: | 105 Citation Court |
| Birmingham, AL 35209 | |
| Contact Person: | Mark Rohrer |
| Telephone: | |
| Email: | 205-290-8251 - phone |
| ssmed@bellsouth.net | |
| Preparation Date: | February 15, 2011 |
| Device Trade Name: | Triplex Er:YAG / Nd:YAG Laser System |
| Common Name: | ER:YAG Laser and Nd:YAG Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Marketed Predicate | |
| Legally | |
| Device: | MLT Erbium:YAG Laser System (K)032599 |
| Ultralight II Nd:YAG Laser System (K)082407 | |
| Description of the Triplex | |
| Er:YAG / Nd:YAG Laser System: | The Apex system and controls are contained in a single |
| console. Electrical power is supplied to the console by the | |
| facility's power source. There are 2 handpieces with the | |
| system. One is an Er:YAG laser which contains the laser | |
| cavity in the head of the handpiece. The second is an | |
| Intense Pulsed Light. These handpieces can be removed | |
| by the user and interchanged. The Er:YAG Laser energy is | |
| a wavelength of 2940nm. | |
| This handpiece can be removed and replaced with a q- | |
| switch Nd:YAG handpeice emitting wavelengths of 1064nm | |
| and 532nm laser energy can be added. | |
| The user activates the laser emission by means of a | |
| footswitch. | |
| Intended use of the Triplex | |
| Er:YAG / Nd:YAG Laser | |
| System: | 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). |
1
The Nd:YAG handpiece is indicated for:
- At the 1064nm wavelength dark ink tattoo removal, . removal of pigmented lesions and the removal or lightening of hair.
- At the 532nm wavelength removal of red ink . tattoos, treatment of vascular lesions including facial telangiectasias, as, angiomas, and leg veins, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
None Performance Data:
Results of Clinical Study: None
Summary of Technological Characteristics:
| | Sandstone Medical
Technologies LLC Triplex
Er:YAG / Nd:YAG System | Sandstone Medical
Technologies LLC Nd:YAG
(Predicate Device) |
|-----------------|-------------------------------------------------------------------------|--------------------------------------------------------------------|
| Energy | Up to 1000mJ | Up to 1000mJ |
| Maximum Fluence | 12J/cm2 | 12J/cm2 |
| Wavelength | 1064nm and 532nm | 1064nm and 532nm |
| Spot Size | up to 5mm | up to 5mm |
| Pulse Width | 10ns | 10ns |
| Repetition Rate | 1-5Hz | 1-5Hz |
| Aiming Beam | HeNe | HeNe |
| Sandstone Medical
Technologies LLC Triplex
Er:YAG / Nd: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 hs | 300 hs |
| 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 |
2
KIJOSUL
l
・。
' . . . . . ·
| Conclusion: | The Triplex Er:YAG / Nd: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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 7 2011
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209
Re: K110502
Trade/Device Name: Triplex Er:YAG / Nd:YAG 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: February 14, 2011 Received: February 22, 201-1
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. 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 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.
Aty B. R. h
her
Mark N. Melkersor 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):
Triplex Er:YAG / Nd:YAG Laser System Device Name:
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).
The Nd:YAG handpiece is indicated for:
- At the 1064nm wavelength dark ink tattoo removal, removal of pigmented o lesions and the removal or lightening of hair.
- At the 532nm wavelength removal of red ink tattoos, treatment of vascular . lesions including facial-and-leg-veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
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)
Page 1 of 1
Nilk R Ogden for mkm
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number