Sterling Supreme Diode Laser
FDA 510(k) K171986 · CAO Group, Inc.
510(k) numberK171986
Submission
- Device name
- Sterling Supreme Diode Laser
- Applicant
- CAO Group, Inc.
West Jordan, UT, US - Received
- July 3, 2017
- Decision date
- September 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| 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 |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K254197 | Picasso Pro Diode Laser (002-00460)GEX · Traditional | 03/11/2026SE |
| K201904 | Monet Curing LaserQNF · Traditional | 11/24/2020SE |
| K201475 | Ultimate Contour, Ultimate Contour MiniPBX · Traditional | 10/28/2020SE |
| K181614 | Sterling Supreme Diode LaserGEX · Traditional | 09/10/2019SE |
| K181602 | Pioneer Elite Diode LaserGEX · Traditional | 09/10/2019SE |
| K181601 | Precise SHP Diode LaserGEX · Traditional | 09/09/2019SE |
| K171052 | Ultimate Contour, Ultimate Contour MiniPBX · Traditional | 10/20/2017SE |
| K160413 | Sterling 5W Diode LaserGEX · Traditional | 09/21/2016SE |
| K150585 | Ascent 3DEBZ · Abbreviated | 12/31/2015SE |
| K142226 | Pilot Ultra Diode LaserGEX · Special | 09/12/2014SE |
Questions and answers
When was Sterling Supreme Diode Laser cleared by the FDA?
Sterling Supreme Diode Laser (K171986) received a 510(k) decision of Substantially Equivalent on September 22, 2017, 81 days after the submission was received.
What is the product code of K171986?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.