← Product Code [PBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX) · K122389 # TRUSCULPT (K122389) _Cutera, Inc. · PBX · Nov 2, 2012 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K122389 ## Device Facts - **Applicant:** Cutera, Inc. - **Product Code:** [PBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX.md) - **Decision Date:** Nov 2, 2012 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The truSculpt infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. ## Device Story truSculpt is an electrosurgical device utilizing radiofrequency (RF) and optional infrared energy to provide topical heating. Device operates by elevating tissue temperature to treat pain, muscle spasms, and improve local circulation; also includes a massage function for temporary reduction in cellulite appearance. Used in clinical settings by trained professionals. Output is thermal energy delivered to target tissue; healthcare providers use device to manage musculoskeletal symptoms and aesthetic concerns. Benefits include non-invasive symptom relief and temporary cosmetic improvement. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Electrosurgical device (21 CFR 878.4400). Energy source: Radiofrequency (RF) and optional infrared. Delivery: Topical heating via handpiece. Class II device. Sterilization: Not specified. Connectivity: Standalone. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - Cutera Titan ([K042638](/device/K042638.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}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Letter Dated: November 2, 2012 Cutera, Incorporated % Ms. Connie Hoy Vice President, Regulatory Affairs 3240 Bayshore Boulevard Brisbane, California 94005 Re: K122389 Trade/Device Name: truSculpt Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: October 04, 2012 Received: October 05, 2012 Dear Ms. Hoy: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ ## Page 2 - Ms. Lynnette Whitaker forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Mark N. Melkerson Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Indications For Use K12238 510(k) Number (if Known): Device Name: truSculpt Indications For Use: The truSculpt infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. r Prescription Use ﺗ (Per 21 CFR 801.109) OR Over-The-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalnation (ODE) (Division Sign-Off) Division of Surgical, Orthopedi : , and Restorative Devices 510(k) Number. K122389 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K122389](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K122389) **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