(155 days)
Not Found
No
The device description focuses on mechanical components for vacuum-assisted liposuction and does not mention any software or algorithms that would suggest AI/ML capabilities. The performance studies are bench tests of mechanical and functional aspects.
No
This device is for aesthetic body contouring through the removal of tissue/fluid (liposuction), not for treating a disease or health condition.
No
The device is described as a "surgical device" indicated for the "removal of tissue or fluid" during "general liposuction procedures for the purpose of aesthetic body contouring." Its function is to remove excess adipose tissue, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components such as a handpiece, console, tubing, and foot pedal, indicating it is a physical medical device system, not software-only.
Based on the provided information, the AirSculpt Body Contouring System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description details a surgical device used for vacuum-suction removal of adipose tissue. It includes components like a handpiece, console, tubing, and foot pedal, all designed for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the AirSculpt Body Contouring System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AirSculpt Body Contouring System is indicated for the removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring.
Product codes
OPB, QPB
Device Description
The AirSculpt System is a surgical device designed of subcutaneous adipose tissue during liposuction procedures performed for cosmetic purposes. The AirSculpt System includes components necessary for the vacuum-suction removal of excess adipose tissue from the body, including a handpiece that accommodates the interchangeability of lipoplasty cannulae, a console for centralized control of the system, tubing to facilitate aspiration of subcutaneous adipose tissue, and a foot pedal for operation. Other elements necessary for the use of the AirSculpt System include commonly used Class I and Class II surgical devices such as lipoplasty cannula that are introduced into the patient and swept over subcutaneous adipose tissue for suction removal and a suction canister into which aspirated adipose tissue is collected. An optional use Instrument Sleeve accessory is also available for use with the AirSculpt Handpiece and its use is based purely on physician preference.
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
Not Found
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
Bench testing included visual and inspection that included performance testing, shelf-life testing, functional testing (connector, operation, indicators, and pneumatic safety). Testing verified that the AirSculpt Body Contouring System conforms to specification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 27, 2024
Cellmyx Jacqueline Schmainda Regulatory Consultant 6352 Corte Del Abeto Suite A Carlsbad, California 92011
Re: K241835
Trade/Device Name: AirSculpt Body Contouring System (AIRS-1-SYS) Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: OPB Dated: October 30, 2024 Received: October 30, 2024
Dear Jacqueline Schmainda:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alicia Hemphill
-S
Digitally signed by Alicia Hemphill -S
Date: 2024.11.27 16:23:04 -06'00'
Alicia Hemphill Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
| AirSculpt Body Contouring System (AIRS-1-SYS) | |
|---|---|
| ----------------------------------------------- | -- |
Indications for Use (Describe)
The AirSculpt Body Contouring System is indicated for the removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring.
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)
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510(k) #: K241835
510(k) Summary
Prepared on: 2024-10-30
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5
| Applicant Name | Cellmyx |
|---|---|
| Applicant Address | 6352 Corte Del Abeto Suite A Carlsbad CA 92011 United States |
| Applicant Contact Telephone | 909-215-1059 |
| Applicant Contact | Mr. Greg Miles |
| Applicant Contact Email | greg@cellmyx.com |
| Correspondent Name | Jacqueline Schmainda |
| Correspondent Address | null United States |
| Correspondent Contact Telephone | 763-269-2069 |
| Correspondent Contact | Ms. Jacqueline Schmainda |
| Correspondent Contact Email | jaschmainda@gmail.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | AirSculpt Body Contouring System (AIRS-1-SYS) |
|---|---|
| Common Name | Suction lipoplasty system |
| Classification Name | System, Suction, Lipoplasty For Removal |
| Regulation Number | 878.5040 |
| Product Code(s) | QPB |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K010311 | Lipomatic; Lipomatic Liposuction Device | QPB |
Device Description Summary 21 CFR 807.92(a)(4)## Device Description Summary
The AirSculpt System is a surgical device designed of subcutaneous adipose tissue during liposuction procedures performed for cosmetic purposes. The AirSculpt System includes components necessary for the vacuum-suction removal of excess adipose tissue from the body, including a handpiece that accommodates the interchangeability of lipoplasty cannulae, a console for centralized control of the system, tubing to facilitate aspiration of subcutaneous adipose tissue, and a foot pedal for operation. Other elements necessary for the use of the AirSculpt System include commonly used Class I and Class II surgical devices such as lipoplasty cannula that are introduced into the patient and swept over subcutaneous adipose tissue for suction removal and a suction canister into which aspirated adipose tissue is collected. An optional use Instrument Sleeve accessory is also available for use with the AirSculpt Handpiece and its use is based purely on physician preference.
Intended Use/Indications for Use
5
The AirSculpt Body Contouring System is indicated for the removal of tissue or fluid from the body during general liposuction procedures for the purpose of aesthetic body contouring.
Indications for Use Comparison
The indications for use of the subject and predicate devices are the same.
Technological Comparison
Performance Data The AirSculpt Body Contouring System has undergone bench testing with passing results: Bench testing IEC 60601-1 Edition 3.2 2020-08 IEC 60601-1-2 Edition 4.1 2020-09 Cleaning and reprocessing validation
AirSculpt Triple Port Tubing: ANSI AMMI ISO 11137-1:2006/(R)2015 ISTA ЗА ASTM F88 ASTM F2096-11
Clinical Data Clinical data was not required to support the substantial equivalence of the AirSculpt Body Contouring System to the predicate device.
Conclusion
The AirSculpt Body Contouring System is substantially equivalent to the predicate device and any differences do not raise new questions of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Bench testing included visual and inspection that included performance testing, shelf-life testing, functional testing (connector, operation, indicators, and pneumatic safety. Testing verified that the AirSculpt Body Contouring System conforms to specification.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)