SmoothCool HR System
FDA 510(k) K213484 · Jeisys Medical, Inc.
510(k) numberK213484
Submission
- Device name
- SmoothCool HR System
- Applicant
- Jeisys Medical, Inc.
Seoul, KR - Received
- October 29, 2021
- Decision date
- April 20, 2022
- 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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| K223685 | SmoothCool HR SystemGEX · Special | 01/04/2023SE |
| K201685 | PotenzaGEI · Traditional | 01/19/2021SE |
| K192545 | PotenzaGEI · Traditional | 02/20/2020SE |
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Questions and answers
When was SmoothCool HR System cleared by the FDA?
SmoothCool HR System (K213484) received a 510(k) decision of Substantially Equivalent on April 20, 2022, 173 days after the submission was received.
What is the product code of K213484?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.