Elite iQ PRO (M122K1)
FDA 510(k) K240396 · Cynosure, LLC
510(k) numberK240396
Submission
- Device name
- Elite iQ PRO (M122K1)
- Applicant
- Cynosure, LLC
Wesford, MA, US - Received
- February 8, 2024
- Decision date
- March 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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| K182741 | SculpSurePKT · Traditional | 01/03/2019SE |
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Questions and answers
When was Elite iQ PRO (M122K1) cleared by the FDA?
Elite iQ PRO (M122K1) (K240396) received a 510(k) decision of Substantially Equivalent on March 8, 2024, 29 days after the submission was received.
What is the product code of K240396?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.