FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Joylux Intimacy Gel (PG3100)
K Number: K242958
·
Decision Mar 20, 2025
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
1
Review Days
176
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Basic Information
- Device Name
- Joylux Intimacy Gel (PG3100)
- K Number
- K242958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Joylux, Inc.
- Date Received
- September 25, 2024
- Decision Date
- March 20, 2025
- Product Code
- NUC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUC | Lubricant, Personal | FDA class 2 | Obstetrics/Gynecology |
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