Gemini Nova Laser Kit – Demo
Catalogue number 6353, listed by Azena Medical, United States, under Laser, Dental, Soft Tissue. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Gigaalaser Company Ltd. | Wuhan | Hubei | Contract manufacturer | 5 |
Record
| Listed by | Azena Medical, United States |
|---|---|
| FDA product code | NVK |
| Device type | Laser, Dental, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K260765 |
| Record published | 2026-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6353 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EdgePRO™ | US Endodontics, LLC | 25 |
| Gemini EVO | Azena Medical | 6 |
| Gigaa | Gigaalaser Company Ltd. | 4 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 2 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 2 |
| Picasso Pro Disposable Therapy Tip, Curved | CAO Group, Inc. | 1 |
| DentaLaze Kit | Shofu Dental Corp. | 1 |
| Gemini Nova Wand Battery 1pk | Azena Medical | 1 |
| Gemini Nova Laser Kit – US | Azena Medical | 1 |
| Ultrafast Diode Laser | Dentlight Inc. | 1 |
| Gemini Nova Extraoral PBM Adapter kit 25mm | Azena Medical | 1 |
| Picasso Pro Disposable Therapy Tip, Straight | CAO Group, Inc. | 1 |
Showing 12 of 17. All products under Laser, Dental, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260765 | 2026-03-10 |
| K210350 | 2021-11-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.