Vivace needle depth range and granularity
The Vivace device by ShenB Co. allows needle depth to be set from 0.5 to 3.5 mm in 0.1 mm increments. This produces 31 discrete depth settings within the cleared range, the finest granularity in the FDA-cleared RF microneedling category covered in the Pinova catalog. A separate device by Aesthetics Biomedical sold under the Vivace Ultra brand extends the range to 4.0 mm at the same 0.1 mm step, producing 36 settings. Depth granularity matters most when clinics work across facial thin skin, fibrotic dermis, and body subcutaneous tissue with a single device.
The rest of this article maps depth per cartridge family, places Vivace in context across other RF microneedling brands in the Pinova catalog, and explains the 1 MHz versus 2 MHz protocol distinction documented in FDA K193070. For the underlying device profile see the Vivace device profile.
Depth per Vivace cartridge family
The original Vivace device by ShenB Co. is cleared under K150409 and K193070 with a needle extension range of 0.5 to 3.5 mm in 0.1 mm increments. The arithmetic is direct: the difference between the maximum and minimum cleared depth divided by the increment, plus one, equals 31 discrete depth settings. The same step size and range carry across both K-numbers in the SHEnB family.
The Vivace Ultra device by Aesthetics Biomedical (FDA trade name LUDWIG Electrosurgical System, K221574) extends the cleared range to 0.5 to 4.0 mm at the same 0.1 mm increment, which produces 36 settings. The 0.5 mm extension at the upper end is the principal per-family depth difference. The depth step is identical; only the maximum changes.
Because the cartridge families are mechanically incompatible, depth selection in practice is bounded by the device a clinic owns. The Vivace cartridge family article covers the cartridge SKU detail, and the Vivace Ultra depth range article covers the regulatory background for the two device lines.
| Spec | Vivace SHEnB | Vivace Ultra | Sylfirm X Plus | Morpheus8 |
|---|---|---|---|---|
| Minimum depth | 0.5 mm | 0.5 mm | 0.3 mm | 0.5 mm |
| Maximum depth | 3.5 mm | 4.0 mm | 4.0 mm | 4.0 mm in Fractora; T tip fixed at 0.5 mm; body family extended under K240017 |
| Increment | 0.1 mm | 0.1 mm | not specified in FDA Summary | not specified in FDA Summary |
| Total cleared settings | 31 | 36 | not specified in FDA Summary | varies per applicator |
| FDA primary K-number | K150409 + K193070 | K221574 | K200185 | K192695 + K240017 |
When depth granularity matters: per-indication selection
On facial thin skin, including periocular tissue, perioral lines, and forehead, the relevant cleared range typically sits between 0.5 and 1.5 mm. The 0.1 mm increment allows the operator to tune depth across this 1.0 mm window in ten discrete steps. A coarser step would force the operator to choose between a small set of preset depths, which is workable on a single zone but constrains protocols that move between adjacent zones with different skin thicknesses. The Vivace step keeps the protocol decision continuous rather than binary.
On mid-dermal scarring, deeper wrinkles, and fibrotic dermis around the cheeks and lower face, depth selection moves into the 1.5 to 2.5 mm zone. The 0.1 mm step allows per-scar tuning when scar depth varies across the treatment area. The choice between 1.8 mm and 2.2 mm is a routine clinical decision in this zone, and an increment that respects 0.1 mm resolution allows it to be made directly on the device rather than approximated.
For body work, subcutaneous targeting, and scar revision on thicker tissue, depth selection moves into the 2.5 to 3.5 mm zone on Vivace SHEnB or the 2.5 to 4.0 mm zone on Vivace Ultra. The extra 0.5 mm at the upper end of the Vivace Ultra range is the principal protocol-relevant difference between the two devices in this zone. Per-session operator workflow benefits from the same 0.1 mm step at depth, since adjacent body zones with different tissue thicknesses can be addressed without changing cartridges, only by adjusting the depth setting.
Depth in context: Vivace and other RF microneedling brands in the Pinova catalog
Sylfirm X Plus from VIOL covers a depth range of 0.3 to 4.0 mm. The minimum sits 0.2 mm below the Vivace minimum, and the maximum matches the Vivace Ultra cleared maximum. The depth increment is not specified in the FDA Summary, so a like-for-like comparison of step size between Sylfirm X and Vivace is not available from primary sources. The Sylfirm X Plus tips with 0.3 to 4.0 mm depth page lists the catalog.
Scarlet SRF from VIOL does not list a needle depth range in its 510(k) Summary, so a cleared-range comparison is not available from primary sources for that platform. Morpheus8 from InMode covers 0.5 to 4.0 mm in the Fractora applicators under K192695, with the T tip head fixed at 0.5 mm, and an extended depth range on the Body family addressed under K240017. The maximum cleared depth on the Body Applicator is referenced as 8 mm in marketing materials; the K240017 Summary does not state the 8 mm figure directly, so depth on the Body family is attributed to manufacturer documentation in this article. The Morpheus8 applicators with depth up to 8 mm page lists the catalog.
The Pinova catalog covers tips and cartridges for each line. The depth ranges are different by design across the platforms; the choice between them rests with the clinical protocol and the practitioner.
Protocol settings: 1 MHz versus 2 MHz cleared use in K193070
K193070 added a 2 MHz operating mode to the original Vivace platform, which had been cleared at 1 MHz only under K150409. The K193070 indications language draws an explicit distinction between the two frequencies. The literal text from the K193070 indications 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 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 implication for clinical protocol design is concrete. Wrinkle protocols on Vivace stay on the 1 MHz setting for alignment with the cleared use language. The 2 MHz setting is cleared for general electrosurgery (electrocoagulation and hemostasis) but was not evaluated for wrinkle treatment in the K193070 submission. Vivace Ultra, separately cleared under K221574, operates at three frequencies (0.5 MHz, 1 MHz, and 2 MHz) and carries a narrower intended use that does not include the percutaneous treatment of facial wrinkles language. The frequency-protocol relationship therefore differs between the two device families. The K193070 file is available as K193070 510(k) Summary.
Professionally sourced Vivace cartridges for protocol workflows
Pinova carries professionally sourced Vivace and Vivace Ultra cartridges across the depth range covered by each device's FDA clearance. Clinics running depth-driven protocols across facial, mid-dermal, and body zones benefit from holding cartridge stock matched to the cartridge family in use, since cartridges are single-use, lot-tracked consumables and the cartridge family is bounded by the device a clinic owns. Browse the available stock on the Vivace tip selection for depth protocols page.
Frequently asked questions
How many depth settings does Vivace have?
The Vivace device by ShenB Co. supports 31 discrete depth settings within the cleared range of 0.5 to 3.5 mm at a 0.1 mm step. The separate Vivace Ultra device by Aesthetics Biomedical extends the range to 4.0 mm at the same 0.1 mm step, producing 36 settings.
What is the maximum needle depth on Vivace?
The Vivace SHEnB cartridge supports a maximum cleared depth of 3.5 mm, as documented in the K193070 and K150409 510(k) Summaries. The Vivace Ultra cartridge under K221574 extends the cleared maximum to 4.0 mm.
What is the difference between 1 MHz and 2 MHz on Vivace?
Under K193070, the 1 MHz setting is cleared for dermatologic and general surgical procedures for electrocoagulation and hemostasis and for the percutaneous treatment of facial wrinkles in Fitzpatrick Skin Type I to V. The 2 MHz setting is cleared for electrocoagulation and hemostasis only; the K193070 indications language states that the 2 MHz setting was not evaluated for the percutaneous treatment of facial wrinkles. Wrinkle protocols on Vivace therefore stay on the 1 MHz setting for alignment with the cleared use.
Does Vivace go as deep as Morpheus8?
The Vivace SHEnB cartridge is cleared to 3.5 mm, and the Vivace Ultra cartridge is cleared to 4.0 mm. The Morpheus8 Fractora applicators are cleared to 4.0 mm under K192695, with the T tip fixed at 0.5 mm, and the Morpheus8 Body family carries an extended depth range under K240017. Manufacturer documentation references 8 mm on the Body Applicator; the K240017 Summary does not state the 8 mm figure directly. The two platforms cover different cleared ranges by design.
