← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K110502 # TRIPLEX ER. YAG / ND: YAG SYSTEM (K110502) _Sandstone Medical Technologies, LLC · GEX · Apr 27, 2011 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K110502 ## Device Facts - **Applicant:** Sandstone Medical Technologies, LLC - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Apr 27, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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) ## Device Story Triplex Er:YAG / Nd:YAG Laser System is a console-based surgical laser for dermatology and plastic surgery. System utilizes two interchangeable handpieces: an Er:YAG laser (2940nm) for skin ablation, dermabrasion, wrinkle treatment, and soft tissue surgery; and a Q-switched Nd:YAG laser (1064nm/532nm) for tattoo removal, pigmented/vascular lesion treatment, and hair removal. Physician operates system via footswitch. Laser energy is delivered to target tissue; clinical effect depends on wavelength-specific absorption. System provides clinicians with a multi-functional tool for aesthetic and surgical procedures, enabling precise tissue interaction based on selected handpiece and parameters. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on bench testing and comparison of technical specifications to predicate devices. ## Technological Characteristics Console-based laser system with interchangeable Er:YAG (2940nm) and Nd:YAG (1064nm/532nm) handpieces. Er:YAG: 2.4W max power, 8J/cm2 max fluence, 300µs pulse width, 10Hz max rep rate. Nd:YAG: 1000mJ max energy, 12J/cm2 max fluence, 10ns pulse width, 1-5Hz rep rate. HeNe aiming beam. Footswitch activation. ## Regulatory 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. ## Predicate Devices - MLT Erbium:YAG Laser System ([K032599](/device/K032599.md)) - Ultralight II Nd:YAG Laser System ([K082407](/device/K082407.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## Attachment 5 510(K) Summary Triplex Er:YAG / Nd:YAG Laser System K110502 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}------------------------------------------------ K110502 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K110502](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K110502) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com