Surgilase/Op 15, 20, 25, 30, 40, 50 CO2 Surg. Lase
FDA 510(k) K932421 · Surgilase, Inc.
510(k) numberK932421
Submission
- Device name
- Surgilase/Op 15, 20, 25, 30, 40, 50 CO2 Surg. Lase
- Applicant
- Surgilase, Inc.
Warwick, RI, US - Received
- May 19, 1993
- Decision date
- October 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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…
Other 510(k)s with product code GEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| 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 |
|---|---|---|
| K924664 | Surgilase Fiberlase CO2 Laser WaveguideGEX · Traditional | 04/15/1993SE |
| K905006 | Surgilase SL 150 Surgical Laser SystemGEX · Traditional | 02/21/1991SE |
| K904203 | Surgilase SL 50/60 Gold Surgical Laser SystemGEX · Traditional | 12/07/1990SE |
| K902211 | Surgilase Yag 100 Surgical Laser SystemGEX · Traditional | 06/29/1990SE |
| K900570 | Surgilase Yag 100 in Orthopedic SurgeryGEX · Traditional | 05/01/1990SE |
| K901227 | Surgilase CO2 Surgical Laser Systems Model SL120GEX · Traditional | 04/26/1990SE |
| K901211 | Surgilase SL50 Surgical Laser SystemGEX · Traditional | 04/26/1990SE |
| K894471 | Surgiprobes and Surgiscalpes in Head/Neck SurgeryGEX · Traditional | 11/14/1989SE |
| K894396 | Surgilase 25, 40, 45, 55, 60, 80, 100 LaserGEX · Traditional | 08/07/1989SE |
| K891461 | Surgilase Yag 100 Surgical Nd:Yag Laser/Gen SurgGEX · Traditional | 04/06/1989SE |
Questions and answers
When was Surgilase/Op 15, 20, 25, 30, 40, 50 CO2 Surg. Lase cleared by the FDA?
Surgilase/Op 15, 20, 25, 30, 40, 50 CO2 Surg. Lase (K932421) received a 510(k) decision of Substantially Equivalent on October 15, 1993, 149 days after the submission was received.
What is the product code of K932421?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.