Accent XL
FDA 510(k) K160075 · Alma Lasers, Inc.
510(k) numberK160075
Submission
- Device name
- Accent XL
- Applicant
- Alma Lasers, Inc.
Buffalo Grove, IL, US - Received
- January 14, 2016
- Decision date
- August 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5300
- Specialty
- Physical Medicine
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Questions and answers
When was Accent XL cleared by the FDA?
Accent XL (K160075) received a 510(k) decision of Substantially Equivalent on August 17, 2016, 216 days after the submission was received.
What is the product code of K160075?
The FDA product code is IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5300.