Vivace versus Vivace Ultra: same brand name, two devices

Vivace and Vivace Ultra are two separate FDA-cleared RF microneedling devices from two separate sponsors. The original Vivace is cleared under K150409 (2016) and K193070 (2021), with ShenB Co. of Seoul, Korea as the sponsor. Vivace Ultra is cleared under K221574 (2022) by Aesthetics Biomedical of Phoenix, Arizona; its FDA trade name is "LUDWIG Electrosurgical System," and Vivace Ultra is the brand name used in the GUDID record. The two devices have separate predicate chains, different needle counts (36 versus 60), and mechanically incompatible cartridges.

The sections below cover the regulatory identity of each device, the manufacturer history behind the naming overlap, the cartridge compatibility implication, a clinic-side verification procedure, and a short note on the "Vivace laser" search question.

Vivace (ShenB Co.): K150409 and K193070

The original Vivace device was first cleared under K150409 on January 15, 2016. The sponsor at that time was Sung Hwan E&B Co., Ltd., the former corporate name of ShenB Co. The clearance letter records the trade name as VIVACE Electrosurgical System, with product code OUH, regulation 21 CFR 878.4400, and Class II status. The predicate was K121481, the INFINI Radiofrequency System from Lutronic. The cleared specifications at that point covered 1 MHz operation and a 36-electrode 6×6 cartridge with depth from 0.5 to 3.5 mm in 0.1 mm increments. The indications for use language reads:

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 full file is available as K150409 in the FDA 510(k) database.

A second clearance, K193070, was granted on April 26, 2021. By that time the sponsor name had shifted to ShenB Co. The K193070 trade name on the FDA letter is VIVACE Electrosurgical Device. K193070 added GEI as a second product code alongside OUH and used K150409 as its self-predicate, with K170325 (Secret RF from ILOODA) as a reference predicate for the new 2 MHz functionality. The cartridge and depth range did not change; the principal addition was the 2 MHz operating mode. The K193070 letter records Aesthetics Biomedical, Inc. of Phoenix, Arizona as the official correspondent on the submission, which captures the distribution relationship that existed at the time. The K193070 file is available as K193070 in the FDA 510(k) database. For the broader device profile, see the Vivace (SHEnB) overview.

Vivace Ultra (Aesthetics Biomedical): K221574 (LUDWIG)

Vivace Ultra was cleared under K221574 on October 16, 2022. The sponsor on the FDA letter is Aesthetics Biomedical, Inc. of Phoenix, Arizona. The FDA trade name on the clearance is "LUDWIG Electrosurgical System." The brand name "VIVACE ULTRA" appears in the AccessGUDID record under Aesthetics Biomedical's catalog, with HIBCC as the issuing agency and the G055 device-identifier prefix. The distinction between the FDA trade name and the GUDID brand name matters for clinic-side verification: a search of the FDA 510(k) database for "Vivace Ultra" will not return K221574 directly, because the trade name on the clearance is LUDWIG. The K221574 file is available as K221574 (LUDWIG).

The predicate chain on K221574 is separate from the original Vivace path. K192545 (Potenza, Jeisys Medical) is the primary predicate, with K180945 (Genius, Lutronic) cited as a reference predicate. Neither K150409 nor K193070 is referenced on K221574. The two clearance histories run in parallel and do not share predicate ancestry.

The K221574 cleared device covers 60 needles in a square pattern, stainless-steel construction, depth from 0.5 to 4.0 mm at a 0.1 mm step, triple-frequency operation at 0.5 MHz, 1 MHz, and 2 MHz, and a maximum RF output of 50 W. A separate ultrasound visualization handpiece (product code IYO, GMDN 35527) is also covered under the same clearance. The indications language is narrower than the Vivace SHEnB indications:

The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The K221574 indications do not include the percutaneous treatment of facial wrinkles language that appears in K150409 and K193070. The depth specifications per family are covered in the depth specifications per family article.

Cartridge compatibility: two families, two SKU catalogs

The original Vivace cartridge under SHEnB carries 36 needles in a 6×6 array. The AccessGUDID record under SHEnB lists the VIVACE Microneedle Cartridge at Primary DI 08800017100234, with packaging variants at 08800017100340, 08800017100357, and 08800017100364. The catalog number field is not populated on the SHEnB cartridge records; only the Primary DI is available for identification.

The Vivace Ultra cartridge family under Aesthetics Biomedical is structured around 16 catalog SKUs in AccessGUDID, all under the HIBCC issuing agency with the G055 prefix. The SKU series covers the system level (ABMVIVS01), the RF applicator (ABMVIVR01), the ultrasound handpiece (ABMVIVU01), and the cartridge series ABMVIVM01 through ABMVIVM10. Within the cartridge series, ABMVIVM05 and ABMVIVM09 are insulated; ABMVIVM06 and ABMVIVM10 are non-insulated. M09 and M10 carry the 60-needle large-area configuration, and M05 and M06 carry the individual standard configuration. M01 through M04 cover custom small-area variants.

The two cartridge families are mechanically incompatible. Needle count differs (36 versus 60), needle pattern differs (6×6 grid versus 60-pin square), and the mounting interface between cartridge and handpiece is not shared between the two device lines. A cartridge from one family does not physically fit the other device. The Vivace and Vivace Ultra products are not successive generations of one line. They are separate pathway clearances from separate sponsors. The cartridge family compatibility procedure article covers the cartridge SKU detail in full.

Manufacturer history: the SHEnB to VYBE RF rebrand

Sung Hwan E&B (later renamed ShenB Co.) and Aesthetics Biomedical worked together for several years in the period covering K150409 and K193070. Aesthetics Biomedical served as the official correspondent on K193070, reflecting an established US distribution relationship. That relationship ended after K193070. Following the split, 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 partnership with Cartessa Aesthetics. The AccessGUDID record under SHEnB lists the brand "VYBE RF (VIVACE)" at Primary DI 08800017100883, which captures the rebrand in the FDA database.

Aesthetics Biomedical separately obtained K221574 in October 2022 and marketed the resulting device under the brand name "Vivace Ultra." K221574 is a distinct pathway clearance built on its predicate chain (Potenza, Genius). It is not a successor to K150409 or K193070. The naming overlap with the original Vivace platform sits at the marketing layer, not at the regulatory layer.

For a clinic, the implication of the split is that service contracts, replacement parts, training, and consumable supply chains run separately. A unit purchased before the split may now be serviced through Cartessa under the VYBE RF or VIVACE PRO brand; a Vivace Ultra unit is supported through Aesthetics Biomedical.

How a clinic verifies which Vivace device it has

Five checks identify the device family unambiguously. Any single check is usually sufficient; together they cross-validate.

1. Check the FDA K-number in the device manual. K150409 or K193070 identifies the original Vivace (SHEnB family). K221574 identifies Vivace Ultra (Aesthetics Biomedical family; FDA trade name LUDWIG Electrosurgical System).
2. Look up the Primary DI from the device or cartridge label in AccessGUDID device lookup. A 0880001710xxxx prefix indicates SHEnB (GS1 issuing agency). A G055xxxxxxxx prefix indicates Aesthetics Biomedical (HIBCC issuing agency).
3. Read the manufacturer label on the device. "ShenB Co." or "Sung Hwan E&B" identifies the original Vivace family. "Aesthetics Biomedical, Inc." identifies Vivace Ultra. After the SHEnB rebrand, newer SHEnB-built units may carry the VYBE RF brand name with ShenB Co. as manufacturer; these still belong to the original Vivace cartridge family.
4. Check the catalog number on the cartridge box where available. An ABMVIVM prefix indicates Aesthetics Biomedical (Vivace Ultra cartridge family). The absence of a catalog number, or an SH-TIP series identifier, indicates SHEnB (Vivace cartridge family).
5. Check the service contract paperwork. Cartessa Aesthetics service points to the SHEnB family (post-rebrand VYBE RF). Aesthetics Biomedical service points to Vivace Ultra (LUDWIG).

"Vivace laser" disambiguation: not a separate FDA-cleared product

The search term "Vivace laser" appears in clinic-side queries but does not match a separately cleared product. Neither the original Vivace nor Vivace Ultra is a laser device. The product codes on the relevant clearances are OUH and GEI (electrosurgical) on Vivace, and GEI, OUH, and IYO (electrosurgical plus ultrasound imaging) on Vivace Ultra. None of these are laser product codes.

A search of AccessGUDID for "Vivace" returns thirty records. Of these, twenty-one are RF microneedling devices from SHEnB or Aesthetics Biomedical; six are spectacle frames from Masunaga Optical; three are hearing aid records from Coselgi (Widex A/S). No records under the search term "Vivace" carry a laser product code. Clinics that operate both a Vivace device and a laser platform are running two separate devices; the laser is not part of the Vivace clearance.

Professionally sourced Vivace cartridges across both families

Pinova carries professionally sourced cartridges for both Vivace families, with separate SKUs for the original Vivace (SHEnB) and Vivace Ultra (Aesthetics Biomedical, FDA trade name LUDWIG) device types. Compatibility is based on industry-standard usage and clinical experience; verify the FDA K-number applicable to your device before ordering. Browse the available stock on the Vivace cartridges (verify family before ordering) page.

Frequently asked questions

Is Vivace the same as Vivace Ultra?

No. The two products are separate FDA-cleared devices from separate sponsors. The original Vivace is cleared under K150409 and K193070, sponsored by ShenB Co. of Seoul, Korea. Vivace Ultra is cleared under K221574, sponsored by Aesthetics Biomedical of Phoenix, Arizona. The FDA trade name on K221574 is LUDWIG Electrosurgical System. The two cartridge families are mechanically incompatible.

Who manufactures Vivace Ultra?

Vivace Ultra is manufactured by Aesthetics Biomedical, Inc., based in Phoenix, Arizona. The FDA trade name on the clearance (K221574, October 2022) is LUDWIG Electrosurgical System. "Vivace Ultra" is the brand name used by Aesthetics Biomedical in the AccessGUDID record and in marketing, but the trade name on the FDA letter is LUDWIG.

Are Vivace and Vivace Ultra cartridges interchangeable?

No. The original Vivace cartridge carries 36 needles in a 6×6 array; the Vivace Ultra cartridge carries 60 needles in a square pattern. The mounting interface differs as well. A cartridge from one family does not fit the other device.

What FDA clearance does Vivace Ultra have?

Vivace Ultra is cleared under K221574, decision date October 16, 2022. The FDA trade name on the letter is LUDWIG Electrosurgical System. The clearance is Class II under 21 CFR 878.4400, with product codes GEI, OUH, and IYO (the last for the ultrasound visualization handpiece included in the system).

Does Vivace have a laser?

No. The original Vivace and Vivace Ultra are both bipolar RF microneedling devices. The product codes on the FDA clearances cover electrosurgical and ultrasound imaging functions; no laser product code appears under the "Vivace" search results in AccessGUDID. Clinics that operate a Vivace device alongside a separate laser platform are running two distinct devices.