What is the Vivace RF microneedling device?
Vivace is a bipolar radiofrequency microneedling system manufactured by ShenB Co., Ltd. of Seoul, Korea (formerly Sung Hwan E&B). The device received FDA 510(k) clearance K150409 in January 2016 and was extended under K193070 in April 2021 to add a 2 MHz operating mode alongside the original 1 MHz. The system uses a 36-electrode cartridge in a 6×6 array, with needle depth adjustable from 0.5 to 3.5 mm in 0.1 mm increments. A separate device sold under the brand name "Vivace Ultra" was cleared in 2022 by Aesthetics Biomedical, Inc. and is covered in a dedicated comparison article.
The Vivace Ultra device deserves an explicit note up front. Its FDA trade name is LUDWIG Electrosurgical System, and its sponsor is Aesthetics Biomedical of Phoenix, Arizona. It uses a different predicate chain and a 60-needle square cartridge that is mechanically incompatible with the 36-needle 6×6 Vivace cartridge. Clinics ordering replacement consumables should confirm which device they own. See Vivace versus Vivace Ultra: two devices, two manufacturers for the full identity walk-through, which also addresses the "Vivace laser" search question (neither device is a laser system).
How Vivace works: bipolar RF through a 36-needle cartridge
Vivace delivers radiofrequency energy into the dermis through a single-use cartridge that mounts on the handpiece. Each cartridge presents 36 needles in a 6×6 array, each needle with an outer diameter of 0.3 mm. The system operates in bipolar mode, with the RF current returning through the cartridge rather than through a remote return electrode.
Under K150409, the device was cleared at 1 MHz with a maximum RF output of 61.5 W into a 500 ohm load. K193070 added a 2 MHz mode at 23.3 W maximum and reduced the 1 MHz maximum to 36 W. Both frequencies share the same cartridge, depth range, and intensity scale (one to ten levels).
Insulation options on the cartridge are described in manufacturer documentation as either insulated (sometimes referred to as gold-tipped in marketing materials) or non-insulated. The 510(k) Summaries do not specify insulation type or coating material in their indications section. For a cross-brand walk-through of how insulation affects energy delivery and clinical decision logic, see the comparison of insulated and non-insulated RF microneedling tips.
For category context across the broader catalog, the RF microneedling consumables across brands page lists tips and cartridges for the modality.
Cartridge family and depth: 31 settings from 0.5 to 3.5 mm
The Vivace cartridge is sold as a single-use sterile disposable. Sterilization is by ethylene oxide to a sterility assurance level of 10 to the minus six, under ISO 11135. The cartridge is prescription only, in line with the device's general electrosurgical labeling.
Depth on Vivace runs from 0.5 to 3.5 mm in 0.1 mm increments. Mathematically that produces 31 discrete depth settings within the cleared range, which is the finest depth granularity in the RF microneedling category covered by the Pinova catalog. The increment matters most for clinics that move between facial thin skin, mid-dermal scarring, and body subcutaneous work within the same device, since the operator can tune depth per anatomic zone without changing cartridge. The needle depth and protocol settings article walks through the per-indication decision logic and places the Vivace range alongside other devices.
The cartridge SKU detail and the cross-family compatibility procedure between the original Vivace and the Vivace Ultra are covered in the dedicated cartridge article in this series.
FDA clearance status: K150409 and K193070
The original Vivace clearance, K150409, was granted to Sung Hwan E&B (the former name of ShenB Co.) on January 15, 2016. The trade name on the clearance letter is VIVACE Electrosurgical System. The product code is OUH, the regulation is 21 CFR 878.4400, the device is Class II, and the predicate is K121481 (INFINI Radiofrequency System, Lutronic). The literal indications for use, cleared via 510(k) and not approved, read:
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.
The second clearance, K193070, was granted to ShenB Co. on April 26, 2021, under the trade name VIVACE Electrosurgical Device. K193070 added GEI as a second product code alongside OUH and used K150409 as its self-predicate plus K170325 (Secret RF from ILOODA) as a reference predicate for the new 2 MHz functionality. The K193070 indications differentiate between the two frequencies:
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The original K150409 file is available as K150409 in the FDA 510(k) database.
What clinics use Vivace for
Clinics use Vivace for skin laxity, fine lines and wrinkles on the face, scar revision, and texture refinement on facial and select body areas. The treating practitioner determines specific suitability. The FDA-cleared indications cover dermatologic and general surgical procedures for electrocoagulation and hemostasis, plus the percutaneous treatment of facial wrinkles. Per the K150409 labeling, the device is cleared for Fitzpatrick Skin Type I to Skin Type V, which is a wider skin type range than some other RF microneedling devices in the same category.
The 1 MHz versus 2 MHz distinction in K193070 carries a protocol implication. Wrinkle protocols fall under the percutaneous treatment of facial wrinkles indication, which the K193070 labeling cleared only on the 1 MHz setting. The 2 MHz setting is cleared for electrocoagulation and hemostasis but was not evaluated for wrinkle treatment in the K193070 submission. Clinics building wrinkle-focused protocols on Vivace should stay on the 1 MHz setting for alignment with the cleared use language.
Manufacturer context: ShenB Co. and the VYBE RF rebrand
ShenB Co., Ltd., headquartered in Seoul, Korea, sponsored both Vivace clearances. K150409 used the previous corporate name Sung Hwan E&B; by K193070 the sponsor name had shifted to ShenB. Aesthetics Biomedical, Inc. of Phoenix, Arizona served as the official correspondent on K193070, reflecting a US distribution relationship that ran for several years.
That relationship later ended. ShenB rebranded the platform under a new product name, VYBE RF (with a subsequent generation marketed as VYBE RF II), and entered an exclusive North American distribution partnership with Cartessa Aesthetics. The GUDID record under SHEnB lists brand "VYBE RF (VIVACE)" with Primary DI 08800017100883, capturing the lineage in the FDA database.
Aesthetics Biomedical separately obtained its own clearance K221574 in October 2022 under the FDA trade name LUDWIG Electrosurgical System, and markets the resulting device as Vivace Ultra. That device sits on a separate predicate chain (K192545 Potenza, K180945 Genius) and uses a 60-needle cartridge that is not interchangeable with the ShenB 36-needle Vivace cartridge.
Vivace and related RF microneedling brands
Vivace shares its FDA classification with other RF microneedling devices in the Pinova catalog. All sit at Class II under 21 CFR 878.4400 with product code OUH or GEI. The predicate chains, however, are separate. Vivace traces through INFINI K121481 (Lutronic) to K150409 and K193070, with Secret RF K170325 as a reference predicate for the 2 MHz extension. Sylfirm X and Scarlet SRF form the VIOL family, tied together by the shared "Na effect" technology and the predicate path through Celfirm K172023 and Scarlet K180872 to Sylfirm X K200185. Morpheus8 is a third family, predicated on Fractora3D K180189 and cleared under K192695 and K240017 with a distinct coated needle design and an extended depth range covered by the Body Applicator.
Shared FDA classification does not imply a shared technological family. Clinics evaluating tips and cartridges across these brands can review the Sylfirm X overview, the Scarlet SRF overview, and the Morpheus8 overview for parallel device profiles.
Professionally sourced Vivace cartridges: how Pinova carries them
Pinova carries professionally sourced Vivace RF microneedling cartridges. Compatibility is based on industry-standard usage and clinical experience; verify against your specific Vivace generation and handpiece before ordering. Because the Vivace name covers two separate device families with mechanically distinct cartridges, the verification step is operationally significant for procurement teams. For the full cartridge SKU detail and a step-by-step verification procedure, see the Vivace cartridge family overview. Browse the available stock on the Vivace RF microneedling cartridges and tips page.
Frequently asked questions
What is the Vivace RF microneedling device?
Vivace is a bipolar RF microneedling system from ShenB Co. of Seoul, Korea, cleared under FDA 510(k) K150409 (2016) and K193070 (2021). The cartridge carries 36 electrodes in a 6×6 array, with depth from 0.5 to 3.5 mm in 0.1 mm increments.
Is Vivace FDA cleared?
Vivace is cleared via the FDA 510(k) pathway, not approved. K150409 (January 15, 2016) and K193070 (April 26, 2021) classify the device as Class II under 21 CFR 878.4400, product codes OUH (K150409) and OUH plus GEI (K193070). The K150409 sponsor was Sung Hwan E&B, later renamed ShenB Co.
What is the difference between Vivace and Vivace Ultra?
Vivace and Vivace Ultra are two separate FDA-cleared devices from two separate sponsors. ShenB Co. sponsors Vivace under K150409 and K193070. Aesthetics Biomedical sponsors Vivace Ultra under K221574, FDA trade name LUDWIG Electrosurgical System. The cartridges are mechanically incompatible (36 versus 60 needles). See the dedicated disambiguation article in this series for the full walk-through.
Does Vivace have insulated or non-insulated needles?
Manufacturer documentation describes Vivace cartridges in both insulated and non-insulated configurations. The 510(k) Summaries do not specify insulation type. The cross-brand comparison article in this series covers how the choice affects energy delivery and per-indication selection.
What depth range does Vivace cover?
The Vivace cartridge supports needle depth from 0.5 to 3.5 mm in 0.1 mm increments, producing 31 discrete settings within the cleared range. The separate Vivace Ultra device by Aesthetics Biomedical extends the range to 4.0 mm at the same 0.1 mm step.
