The CoolSeal Generator (CSL-200-90) is a radiofrequency system designed exclusively for endometrial ablation in women with heavy menstrual bleeding. It has nothing to do with skin tightening, body contouring, or any aesthetic indication, despite the "cool" branding that might suggest otherwise.

Why mention it? Because device names can be misleading, and it's easy to confuse gynecologic RF with the aesthetic RF platforms you already know. This clearance is a reminder to verify indications before assuming a new "RF generator" belongs in your treatment room.

If a sales rep pitches a "CoolSeal" system, confirm you're discussing the right product category. Hologic is a major women's health company, not an aesthetic manufacturer, and this generator is built for ob-gyn offices and surgical centers.

For full details on the intended use and contraindications, consult the official FDA clearance record.

View the official FDA record ↗

This post summarizes a public FDA database entry for medical-aesthetics owners. It is general business information, not medical, legal, or regulatory advice. Always confirm scope, lot numbers, and classification against the official FDA record, and consult your own clinician or counsel for anything clinical or compliance-related.