BK251268 · Synova Life Sciences, Inc. Los Angeles, CA 90032 · QKL · Nov 17, 2025 · General, Plastic Surgery
Device Facts
Record ID
BK251268
Device Name
Synova Wave Adipose Processing System
Applicant
Synova Life Sciences, Inc. Los Angeles, CA 90032
Product Code
QKL · General, Plastic Surgery
Decision Date
Nov 17, 2025
Decision
SESE
Regulation
21 CFR 878.5040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Synova WAVE system is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
Device Story
Synova WAVE processes lipoaspirate tissue for autologous reinjection; closed-loop system. Components: electromechanical device and sterile single-use 500 mL cartridge. Operation: clinician loads lipoaspirate into cartridge; device uses automated powered impact plate to wash/agitate tissue; saline centrifugation collects processed adipose tissue. Used in operative setting; physician-operated. Output: washed adipose tissue ready for immediate autologous transfer. Benefits: automated processing reduces manual labor compared to predicate; maintains tissue viability for aesthetic contouring.
Clinical Evidence
Bench testing only. Adipocyte viability analysis conducted comparing subject device to predicate device. No clinical data provided.
Technological Characteristics
Electromechanical processing system; 24 VDC power source. Single-use 500 mL cartridge. Automated agitation via powered impact plate. Input/output via self-sealing needleless luer ports and catheter port. 1200 μm mesh filtration. Sterile, single-use disposable components.
Indications for Use
Indicated for patients undergoing aesthetic body contouring (lipofilling) requiring autologous adipose tissue transfer across various surgical specialties including plastic, reconstructive, neuro, gastrointestinal, urological, general, orthopedic, gynecological, thoracic, and laparoscopic surgery.
Regulatory Classification
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 of 1/3 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.
Special Controls
*Classification.* Class II (special controls). Consensus standards and labeling restrictions.
Predicate Devices
Lipogems System (B220703)
Submission Summary (Full Text)
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# **510(K) SUMMARY**
**Synova WAVE Adipose Processing System**
**Prepared on 2025-11-14**
**Application Number:** BK251268
**Contact Details**
Applicant Name: Synova Life Sciences, Inc.
Applicant Address: 1927 Paseo Rancho Castilla Los Angeles CA 90032 United States
Applicant Contact Telephone: 619-796-6821
Applicant Contact: Mr. John Chi
Applicant Contact Email: jchi@synovalife.com
**Device Name:**
Device Trade Name: Synova WAVE Adipose Processing System
Common Name: Suction lipoplasty system
Classification Name: Lipoaspirate Washing System For Aesthetic Body Contouring
Regulatory Number: 878.5040
Product Code: QKL
**Legally Marketed Predicate Devices**
Predicate #: B220703
Predicate Trade Name: Lipogems System
Product Code: QKL
**Device Description Summary**
The Synova WAVE adipose tissue processing system is intended for the closed-loop processing of lipoaspirate tissue for the transferring of adipose tissue. The system consists of two primary components:
a. Synova WAVE device is an electromechanical device that applies energy to the adipose tissue.
b. Synova WAVE disposable, single-use cartridge is a sterile cartridge designed to house the adipose tissue during processing.
The result of processing with the Synova WAVE adipose tissue processing system is washed adipose tissue, which allows a patient's subcutaneous fat to be processed for autologous reinjection within the operative procedure time.
There is no direct interaction of the device with the patient, although the adipose tissue that is processed in the device comes from the patient and is returned to the same patient after processing.
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# Intended Use / Indications for Use
The Synova WAVE system is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
# Indications for Use Comparison
The Indications for Use are the same.
# Technological Comparison
The subject device and the predicate device share many identical or similar features and parameters including the product code and indication for use. Differences exist in the following areas:
- Variations: Predicate has two size variations; Synova has only one size of 500 mL.
- Source of Energy: Predicate uses manual processing; Synova uses 24 VDC power.
- Mechanical Operation: Predicate is processed by hand; Synova is an automated process driven by an electric motor.
- Agitation Mechanism: Predicate uses stainless steel balls that are manually shaken to mechanically impact and agitate the adipose tissue; Synova is automated and electro-mechanically agitates the adipose tissue.
- Fill Volume: Predicate comes in two sizes that can hold a total of 60 mL or 240 mL; Synova is a single size that can hold a total of 500 mL.
- Number of Ports: Predicate has two open luer ports for input and output access; Synova has two self-sealing needleless injection luer ports and one self-sealing catheter port for input and output access.
- Mesh Sizes: Predicate passes adipose tissue through a 2000 μm filter at its luer inlet and a 1000 μm filter at its luer outlet; Synova passes adipose tissue through 1200 μm ports for input and output.
- Tissue Collection: Predicate collects adipose tissue and residual adipose from the container through repeated shaking and draining of saline; Synova collects adipose tissue and residual adipose directly from the cartridge and by centrifuging saline.
The most significant difference between the subject and predicate is that the predicate uses manual shaking to wash and process adipose tissue whereas the Synova WAVE device uses an automated powered impact plate to wash and process adipose tissue. Other differences were only minor variations in size and access.
None of the differences substantively affect the output of the Synova WAVE compared to the predicate device and so do not raise any new concerns for safety or efficacy.
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An adipocyte viability analysis was conducted that compared the subject device to the predicate device. A complete study report is included in this submission.
The totality of performance testing and standards compliance demonstrates that the differences in device design and operation do not raise any new concerns for safety or efficacy, and therefore the subject device and the predicate device are substantially equivalent.
### Non-Clinical and / or Clinical Tests Summary and Conclusions
Cell Viability testing was conducted to compare the results to the predicate device.
