VaporMAX LDD; MOJo LDD; MegaJOULE LDD
FDA 510(k) K233157 · Innovaquartz, LLC
510(k) numberK233157
Submission
- Device name
- VaporMAX LDD; MOJo LDD; MegaJOULE LDD
- Applicant
- Innovaquartz, LLC
Phoenix, AZ, US - Received
- September 27, 2023
- Decision date
- May 3, 2024
- 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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| 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 |
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Questions and answers
When was VaporMAX LDD; MOJo LDD; MegaJOULE LDD cleared by the FDA?
VaporMAX LDD; MOJo LDD; MegaJOULE LDD (K233157) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 219 days after the submission was received.
What is the product code of K233157?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.