Try a real question: “Who can inject Botox in Montana?” or “Is $12 per unit the full price?” The index loads on first use; what you type is matched in this browser.
Product identity
What was that, exactly?
Type the name as it was said to you or printed on the box — or a number from it: an NDC, a device identifier or full UDI, a 510(k), PMA or application number. A name is matched against this site’s registry; a number can be looked up in FDA’s own records, with any recall filed under it. A match says a record exists. It never says the vial or device in front of you is that product.
Try:
A 510(k) number. Press the lookup button to search FDA records.
755 nm (alexandrite): temporary hair reduction, and stable long-term or permanent hair reduction, on all skin types (Fitzpatrick I-VI) including tanned skin
755 nm: benign pigmented lesions, wrinkles, and vascular lesions such as port-wine stains, hemangiomas and telangiectasias
1064 nm (Nd:YAG): removal of unwanted hair for stable long-term or permanent hair reduction and treatment of pseudofolliculitis barbae (razor bumps), on all skin types including tanned skin
1064 nm: pigmented and vascular lesions (such as spider and leg veins, rosacea, warts), coagulation of soft tissue, benign pigmented lesions, and reduction of black or blue-black tattoo intensity
Checking it’s the real thing
No FDA authenticity notice is recorded for this product. Ask: “What’s the brand name printed on the box, vial or device panel — and may I see it?”
Look it up in FDA and National Library of Medicine databases: the record it belongs to, who holds it, and any recall or enforcement report filed under it.
Sends only “K201111” to this site, which asks FDA and the National Library of Medicine. Nothing else on this page or in your Booking File is sent, and nothing is stored.
Your booking file
Record what you found
Did you see GentleMax Pro Plus itself — the box, vial or device panel?
Your file lives in this browser. Recording waits until it has been read.