Hathor Professional Skincare , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147), Sutil Rich Personal Lubricant, Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011)
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hathor Professional Skincare , Ltd. Obstetrics & Gynecology ✕
3 devices
Cleared
Jun 09, 2026
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Obstetrics & Gynecology
270d
Cleared
May 02, 2025
Sutil Rich Personal Lubricant
Obstetrics & Gynecology
60d
Cleared
Jan 21, 2025
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011)
Obstetrics & Gynecology
244d