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510(k) K233689

Hope&Her Vaginal Dilators by Lujena, Inc. — Product Code HDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2024
Date Received
November 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vaginal
Device Class
Class II
Regulation Number
884.3900
Review Panel
OB
Submission Type

Other clearances by Lujena, Inc.

  • K222492 — Hope&Her Vaginal Dilators (June 27, 2023)

Other clearances for product code HDX

  • K241748 — Intimate Rose Vaginal Dilators (August 14, 2024)
  • K222492 — Hope&Her Vaginal Dilators (June 27, 2023)
  • K231430 — Intimate Rose Vaginal Dilators (June 7, 2023)
  • K220035 — Milli Vaginal Dilator (February 27, 2023)
  • K211959 — Milli Vaginal Dilator (December 1, 2021)
  • K130273 — PANPAC VAGINAL DILATORS (August 8, 2013)
  • K071754 — NEO-VAGINA SURGERY SET AND ACCESSORIES (January 7, 2009)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)