Milli Vaginal Dilator
The Milli Vaginal Dilator provides patient controlled dilation for adult women who need vaginal expansion for an examination, surgical preparation or relief of vaginismus and related…
The Milli Vaginal Dilator provides patient controlled dilation for adult women who need vaginal expansion for an examination, surgical preparation or relief of vaginismus and related painful intercourse. It is a prescription device for home or healthcare use.
Electromechanical expansion changes the diameter from 15 to 40 mm in one millimeter increments. Buttons increase or decrease the diameter while the device remains inserted, and the interface displays the selected dilation setting.
Listed Item
Vaginal Dilator
Charging and Controls
The battery powered dilator also offers an optional vibration function. It is supplied with a storage and charging case and a USB adapter. Treatment duration and frequency follow the instructions for use or the prescribing physician’s direction.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Yuxiang Silicone & Plastic Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Materna Medical, United States |
|---|---|
| FDA product code | HDX |
| Device type | Dilator, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K211959 |
| Record published | 2023-01-19 |
| Record revised | 2025-12-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG0330 | In distribution | |
| FG0300 | Withdrawn | |
| FG0330 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dilator, Vaginal | Panpac Medical Corporation | 13 |
| Intimate Rose | Plus EV Holdings Inc | 11 |
| Bioteque | Bioteque Taiwan Ltd. | 11 |
| Bioteque America, Inc. | Bioteque America, Inc. | 11 |
| Hayden Medical | Hayden Medical Inc | 4 |
| Sklar® | Sklar Corporation | 3 |
| Medline | Medline Industries, Inc. | 3 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
| Orthomed | Ortho-MED, Inc. | 1 |
| Dilator, Vaginal | Doppkon Gmbh & Co. KG | 1 |
| Hope&Her Vaginal Dilators | Lujena, Inc. | 1 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220035 | 2023-02-27 |
| K211959 | 2021-12-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.