510(k) K254101

Device: Julva Velvé Water-Based Personal Lubricant
Applicant: Golden Isles Medical, Inc.
510(k) number: K254101
Product code: NUC
Decision: Substantially Equivalent (SESE)
Decision date: 2026-04-16
Date received: 2025-12-19
Regulation: 884.5300
Classification name: Lubricant, Personal
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Louie Goryoka
Address: 134 Indigo Dr. Brunswick GA US 31525 31525

FDA Registration Numbers

2531449
3021033518
3029582965
3013770781
9610200
3014829931
3007829481
3006892202
1831301
3013215912
3003071219
3004569514
3011360380
8040641
3009939047
3010165308
3043139371
3015271338
3040313889
3013395518
3020512730
1649690
3015538858
3029906446
3012404174
3022754162
3010770024
1417367
3009482034
3007957048
3012262584
3036802562
3004737812
3010386378
2020372
3003963141
3039878168
3014759506
3040301765
9680135
3017732703
3008808138
3016842367
3038220293
3010419931
3009599096
3016616658
8020300
1811396
3012194887
3008080893
3003887639
2412672
3008469990
3003823186
2025292
3038613112
3027686087
3016931143
3030155386
3012909279
3013474580
3003676119
1450238
3004079477
3027974197
3010409218
3010164364
3011318803
3019880009
3015391081
1000375074
3004089975
2025771
3011630465
2938651
3003169402
3005113602
3003446042

Source Documents

510(k) summary PDF

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