Silicone Vaginal Dilators 510k FDA Cleared – Vaginismus & Pelvic Pain Relief Dilators for Women – Full Set 8-Pack Sizes 1-8 by Intimate Rose

Price: $159.99
(as of Nov 05, 2025 02:37:24 UTC – Details)

From the brand

Why is it important that the Intimate Rose Dilators are the only FDA-cleared product?

Great question! Intimate Rose Dilators are the only silicone pelvic floor relaxation devices cleared by the FDA (510(k) K241748) to address issues like pelvic pain and vaginismus. This clearance means our product has passed strict testing for safety, quality, and effectiveness. Any other dilators claiming to treat these conditions without FDA clearance are breaking the rules – and putting your health at risk with unverified, potentially dangerous products.

Should I take a chance on non-FDA compliant dilators?

Purchasing a product that breaks the FDA rules is strongly NOT recommended. These products have not been tested for safety, material quality, or effectiveness. If something goes wrong, there’s no oversight and no support. With your body on the line, buying a non-compliant device isn’t just a gamble – it’s a risk you don’t need to take.

Why are other products still being sold if they’re not FDA-cleared?

Because no one’s holding them accountable — and that’s a serious problem. Unregulated products with unproven claims flood the market, putting your health at risk. At Intimate Rose, we refuse to cut corners. We follow FDA guidelines because you deserve products backed by science, not marketing hype.

How do Intimate Rose’s sizes compare to other brands?

More dilators in a set doesn’t always mean better. Many brands include fewer sizes with large, painful jumps between them – making it harder and more uncomfortable to progress. Intimate Rose offers 9 total sizes with our sets featuring gradual increases. Drastic size jumps are not approved by the FDA because they will cause discomfort or injury. Designed by Dr. Amanda Olson, our dilators prioritize your healing—not just a higher piece count.

Who recommends these?

14,000+ pelvic therapists across the USA and even more worldwide trust our dilators in their clinics. Intimate Rose is the go-to brand that is used to train new therapists when getting certified and are the gold standard in pelvic floor care.

Why did the logo move?

We listened to your feedback! The logo is now at the base (not the side) for a smoother, more comfortable experience.

Is Discontinued By Manufacturer ‏ : ‎ No
Department ‏ : ‎ Boys
Date First Available ‏ : ‎ December 21, 2023
Manufacturer ‏ : ‎ Intimate Rose
ASIN ‏ : ‎ B07BKB4NR9
Best Sellers Rank: #103,967 in Health & Household (See Top 100 in Health & Household) #191 in Bladder Control Devices
Customer Reviews: 4.7 4.7 out of 5 stars 122 ratings var dpAcrHasRegisteredArcLinkClickAction; P.when(‘A’, ‘ready’).execute(function(A) { if (dpAcrHasRegisteredArcLinkClickAction !== true) { dpAcrHasRegisteredArcLinkClickAction = true; A.declarative( ‘acrLink-click-metrics’, ‘click’, { “allowLinkDefault”: true }, function (event) { if (window.ue) { ue.count(“acrLinkClickCount”, (ue.count(“acrLinkClickCount”) || 0) + 1); } } ); } }); P.when(‘A’, ‘cf’).execute(function(A) { A.declarative(‘acrStarsLink-click-metrics’, ‘click’, { “allowLinkDefault” : true }, function(event){ if(window.ue) { ue.count(“acrStarsLinkWithPopoverClickCount”, (ue.count(“acrStarsLinkWithPopoverClickCount”) || 0) + 1); } }); });
A Complete Healing Journey – Not Just a Product: More than dilators – this is a true pelvic pain solution. Created by Dr. Amanda Olson, includes expert guidance, 100s of tutorial videos, and round-the-clock support.
FDA-Cleared for Safe, At-Home Use: The only silicone vaginal dilators on Amazon with 510(k) OTC clearance (K241748). Trusted by clinicians for safe, effective vaginismus and pelvic floor therapy from the privacy of your home.
Medical-Grade Silicone, Ultra-Smooth: Premium, body-safe dilators with best-in-class smoothness to ease painful inter-course; logo moved to base for added comfort.
Medical-Grade Silicone, Remarkably Smooth: Made from premium, body-safe silicone with a polished finish for comfort. Thoughtful design includes a base-placed logo to reduce friction and maximize ease of use.
Real Support, Real Results: Get ongoing guidance from Dr. Olson, connect with others in a private support group, and access step-by-step video training. You’re never alone on this journey.