← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K152636 # Laser Dock (K152636) _Patient Pocket, LLC · GEX · Dec 17, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K152636 ## Device Facts - **Applicant:** Patient Pocket, LLC - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Dec 17, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The Laser Dock is designed for use with Ho:YAG, CO2 and KTP laser systems when laser fibers are deployed. ## Device Story Laser Dock is a mechanical accessory designed for use with Ho:YAG, CO2, and KTP laser systems. It functions as a docking or stabilization station for laser fibers during surgical procedures. The device is intended for use in clinical settings by healthcare professionals. It provides a secure interface for laser fiber deployment, assisting in the management of laser delivery systems during surgery. It does not involve electronic processing, software, or automated analysis. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical accessory for laser fiber management. Compatible with Ho:YAG, CO2, and KTP laser systems. Non-electronic, passive device. ## 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. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, one behind the other. 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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Patient Pocket, LLC % Mr. Ray Kelly Licensale Incorporated 57 Lazy Brook Road Monroe, Connecticut 06468 December 17, 2015 Re: K152636 Trade/Device Name: Laser Dock 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: August 27, 2015 Received: September 15, 2015 Dear Mr. Kelly: 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 {1}------------------------------------------------ Page 2 - Mr. Ray Kelly 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. > Sincerely vours. Joshua Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152636 Device Name Laser Dock Indications for Use (Describe) The Laser Dock is designed for use with Ho:YAG, CO2 and KTP laser systems when laser fibers are deployed. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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