Chrysalis Intelligence · Product Codes · HDX

HDX · Unclassified

6 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
6
2021-12-01 → 2024-08-14
Last 12 months
0
Unique sponsors
3
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Lujena, Inc. 2 0 2024-05-02
Materna Medical 2 0 2023-02-27
Plus EV Holdings Dba Intimate Rose 2 0 2024-08-14
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
57400 CPT Medium Dilation of vaginal stricture; nonobstetric
57210 CPT Low Cervical dilation may incorporate vaginal dilator
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-08-14 K241748 Plus EV Holdings Dba Intimate Rose Intimate Rose Vaginal Dilators
2024-05-02 K233689 Lujena, Inc. Hope&Her Vaginal Dilators
2023-06-27 K222492 Lujena, Inc. Hope&Her Vaginal Dilators
2023-06-07 K231430 Plus EV Holdings Dba Intimate Rose Intimate Rose Vaginal Dilators
2023-02-27 K220035 Materna Medical Milli Vaginal Dilator
2021-12-01 K211959 Materna Medical Milli Vaginal Dilator