Smoothlase Alexandrite Laser System
FDA 510(k) K990043 · Leisegang Medical, Inc.
510(k) numberK990043
Submission
- Device name
- Smoothlase Alexandrite Laser System
- Applicant
- Leisegang Medical, Inc.
Boca Raton, FL, US - Received
- January 6, 1999
- Decision date
- February 11, 1999
- 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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| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
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| 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 |
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Questions and answers
When was Smoothlase Alexandrite Laser System cleared by the FDA?
Smoothlase Alexandrite Laser System (K990043) received a 510(k) decision of Substantially Equivalent on February 11, 1999, 36 days after the submission was received.
What is the product code of K990043?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.