Nidek Green Laser Photocoagultor Model GYC-1000 Connected with the Endophotocoagulation Delivery Unit
FDA 510(k) K131894 · Nidek Co., Ltd.
Submission
- Device name
- Nidek Green Laser Photocoagultor Model GYC-1000 Connected with the Endophotocoagulation Delivery Unit
- Applicant
- Nidek Co., Ltd.
Gamagori, JP - Received
- June 25, 2013
- Decision date
- October 31, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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Questions and answers
When was Nidek Green Laser Photocoagultor Model GYC-1000 Connected with the Endophotocoagulation Delivery Unit cleared by the FDA?
Nidek Green Laser Photocoagultor Model GYC-1000 Connected with the Endophotocoagulation Delivery Unit (K131894) received a 510(k) decision of Substantially Equivalent on October 31, 2013, 128 days after the submission was received.
What is the product code of K131894?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.