GentleMax Pro Plus
FDA 510(k) K201111 · Candela Corporation
510(k) numberK201111
Submission
- Device name
- GentleMax Pro Plus
- Applicant
- Candela Corporation
Marlborough, MA, US - Received
- April 27, 2020
- Decision date
- May 26, 2020
- 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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| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
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| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
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| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
More from Rhein Laser Technologies Co., Ltd.
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| K240070 | Profound MatrixGEI · Traditional | 07/01/2024SE |
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| K212492 | Frax 1940 for Nordlys and Frax ProGEX · Traditional | 12/20/2021SE |
| K211217 | Profound MatrixGEI · Traditional | 12/16/2021SE |
| K191685 | PicoWay Laser SystemGEX · Traditional | 09/16/2019SE |
| K183452 | Vbeam Prima Laser SystemGEX · Special | 02/01/2019SE |
| K150326 | PicoWay Laser SystemGEX · Traditional | 04/16/2015SE |
| K140732 | Candela Gentlelase Family of Laser SystemsGEX · Special | 11/07/2014SE |
| K140122 | Candela Gentlemax Family of Laser SystemGEX · Traditional | 05/09/2014SE |
Questions and answers
When was GentleMax Pro Plus cleared by the FDA?
GentleMax Pro Plus (K201111) received a 510(k) decision of Substantially Equivalent on May 26, 2020, 29 days after the submission was received.
What is the product code of K201111?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.