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Sign in to claim this brandLaseroptek Co., Ltd
US
Last updated May 23, 2026
What Laseroptek Co., Ltd makes
Laseroptek Co., Ltd manufactures frequency-doubled solid-state laser systems for general and dermatological surgical applications, including fractional and pico-second handpieces. Their portfolio includes excimer lasers and solid-state laser devices designed for skin treatments and body procedures, such as the HELIOS and HYPERION series. Accessories like handpieces, collimators, and power cables are also part of their product range. These systems are engineered for precision in procedures like skin resurfacing, tattoo removal, and body contouring.
The company’s devices fall under FDA Class II regulation, with authorisations granted through 510(k) clearances and the FDA’s Unique Device Identifier (UDI) program. Their products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. Laseroptek Co., Ltd operates from the United States, adhering to domestic regulatory requirements for laser-based medical technologies.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Laseroptek Co., Ltd manufacture?
Laseroptek Co., Ltd specializes in frequency-doubled solid-state laser systems, primarily for surgical and dermatological use. Their portfolio includes general/multiple surgical laser systems, dermatological laser systems (both frequency-doubled solid-state and excimer types), and accessories like handpieces, collimators, and power cables. Devices such as the HELIOS and HYPERION series are designed for procedures like skin resurfacing, tattoo removal, and body contouring, catering to both aesthetic and medical applications.
Where is Laseroptek Co., Ltd based, and how does this affect its regulatory compliance?
Laseroptek Co., Ltd is based in the United States, which means its devices must comply with FDA regulations. Since their products fall under Class II classification, they undergo 510(k) clearance processes and are required to use FDA’s Unique Device Identifier (UDI) system. This ensures their devices meet US safety and performance standards for medical lasers, including those used in dermatology and general surgery.
Which regulatory registries or databases list Laseroptek Co., Ltd’s devices?
Laseroptek Co., Ltd’s devices are listed in the FDA’s 510(k) clearance database and the FDA’s Unique Device Identifier (UDI) program. These registries confirm that their laser systems—such as the HELIOS and HYPERION series—have undergone the necessary authorisation processes to comply with US medical device regulations. Listing in these databases helps healthcare providers verify regulatory compliance before use.
How are Laseroptek Co., Ltd’s devices classified under FDA regulations?
Laseroptek Co., Ltd’s devices are classified as Class II under FDA regulations. This classification applies to their frequency-doubled solid-state and excimer laser systems, which require pre-market notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device. Class II classification balances regulatory oversight with streamlined approval processes for moderate-risk devices like surgical and dermatological lasers.
What kinds of procedures are Laseroptek Co., Ltd’s laser systems designed for?
Laseroptek Co., Ltd’s laser systems are engineered for precision in dermatological and general surgical applications. Their frequency-doubled solid-state lasers (e.g., HELIOS series) and excimer lasers are used for skin resurfacing, tattoo removal, and pigmentation treatments, while their pico-second and fractional handpieces (e.g., PicoLO, HYPERION Blue) target body contouring, hair removal, and acne treatment. The devices’ versatility allows them to address both cosmetic and clinical needs in dermatology and surgery.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 689856875
Catalogue (162)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PALLAS 308/311 Solid-State UV Laser System | K172639 | FDA 510(k) | Class II | Active |
| Helios III | K152856 | FDA 510(k) | Class II | Active |
| PicoLO Premium | K212573 | FDA 510(k) | Class II | Active |
| HELIOS 785 Pico (1754V2) | K243780 | FDA 510(k) | Class II | Active |
| HELIOS 785 Pico | K230373 | FDA 510(k) | Class II | Active |
| Helios Ii Q-Switched Nd:yag Laser System | K083203 | FDA 510(k) | Class II | Active |
| Helios Iv 785 | K212663 | FDA 510(k) | Class II | Active |
| PicoLO Nd: YAG Picosecond Laser System | K203491 | FDA 510(k) | Class II | Active |
| Lotus Ii Pulsed Er: Yag Laser System | K083253 | FDA 510(k) | Class II | Active |
| PALLAS Premium | K223588 | FDA 510(k) | Class II | Active |
| PicoLO Nd:YAG Picosecond Laser System | K183392 | FDA 510(k) | Class II | Active |
| Lotus III Multi-Pulsed Er: Yag Laser System | K182045 | FDA 510(k) | Class II | Active |
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