Is this your brand? Sign in to claim ownership.
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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689856875
Catalogue (162)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HELIOS 785 Pico 785 Collimator Handpiece | HELIOS 785 Pico 785 Collimator Handpiece | FDA UDI | Class II | Active |
| PALLAS body | PALLAS body | FDA UDI | Class II | Active |
| HELIOS IV 785 DIA FX 785 s Handpiece | HELIOS IV 785 DIA FX 785 s Handpiece | FDA UDI | Class II | Active |
| PicoLO Body | PicoLO Body | FDA UDI | Class II | Active |
| LOTUS Ⅱ Arm | LOTUS Ⅱ Arm | FDA UDI | Class II | Active |
| HELIOS III User Manual | HELIOS III User Manual | FDA UDI | Class II | Active |
| PALLAS Arm | PALLAS Arm | FDA UDI | Class II | Active |
| PALLAS Premium Foot Switch | PALLAS Premium Foot Switch | FDA UDI | Class II | Active |
| HELIOS IV 785 Body | HELIOS IV 785 Body | FDA UDI | Class II | Active |
| HELIOS Ⅱ Arm | HELIOS Ⅱ Arm | FDA UDI | Class II | Active |
| PicoLO Premium User Manual | PicoLO Premium User Manual | FDA UDI | Class II | Active |
| HELIOS Ⅱ Service Manual | HELIOS Ⅱ Service Manual | FDA UDI | Class II | Active |
| LOTUS Ⅱ body | LOTUS Ⅱ body | FDA UDI | Class II | Active |
| HELIOS IV 785 1064 FX Handpiece | HELIOS IV 785 1064 FX Handpiece | FDA UDI | Class II | Active |
| PALLAS Premium Handpiece - 12 x 12 | PALLAS Premium Handpiece - 12 x 12 | FDA UDI | Class II | Active |
| HELIOS III body | HELIOS III body | FDA UDI | Class II | Active |
| HELIOS Ⅱ body | HELIOS Ⅱ body | FDA UDI | Class II | Active |
| PicoLO Premium Foot Switch | PicoLO Premium Foot Switch | FDA UDI | Class II | Active |
| LOTUS III User Manual | Rev.3 | FDA UDI | Class II | Active |
| PALLAS Service Manual | PALLAS Service Manual | FDA UDI | Class II | Active |
| HELIOS 785 Pico DIA FX 785 Handpiece | HELIOS 785 Pico (1754V2) DIA FX 785 Handpiece | FDA UDI | Class II | Active |
| HELIOS 785 Pico Zoom Handpiece | HELIOS 785 Pico (1754V2) Zoom Handpiece | FDA UDI | Class II | Active |
| HELIOS IV 785 Foot Switch | HELIOS IV 785 Foot Switch | FDA UDI | Class II | Active |
| HELIOS 785 Pico 785 Zoom Handpiece | HELIOS 785 Pico (1754V2) 785 Zoom Handpiece | FDA UDI | Class II | Active |
| HYPERION Arm | HYPERION Arm | FDA UDI | Class II | Active |
| PALLAS Service Manual | PALLAS Service Manual | FDA UDI | Class II | Active |
| HELIOS Ⅱ 1064 Fractional Handpiece | HELIOS Ⅱ 1064 Fractional Handpiece | FDA UDI | Class II | Active |
| LOTUS III Foot Switch | LOTUS III Foot Switch | FDA UDI | Class II | Active |
| HELIOS III 1064 Handpiece | HELIOS III 1064 Handpiece | FDA UDI | Class II | Active |
| HELIOS 785 Pico DIA FX 785 Handpiece | HELIOS 785 Pico DIA FX 785 Handpiece | FDA UDI | Class II | Active |
| HELIOS Ⅲ Power Cable | HELIOS Ⅲ Power Cable | FDA UDI | Class II | Active |
| PicoLO User Manual | PicoLO User Manual | FDA UDI | Class II | Active |
| PALLAS body | PALLAS body | FDA UDI | Class II | Active |
| HELIOS Ⅱ User Manual | HELIOS Ⅱ User Manual | FDA UDI | Class II | Active |
| PALLAS power cable | PALLAS power cable | FDA UDI | Class II | Active |
| HELIOS IV 785 Arm | HELIOS IV 785 Arm | FDA UDI | Class II | Active |
| LOTUS Ⅱ Zoom Handpiece | LOTUS Ⅱ Zoom Handpiece | FDA UDI | Class II | Active |
| PicoLO Zoom Handpiece | PicoLO Zoom Handpiece | FDA UDI | Class II | Active |
| PicoLO Body | PicoLO Body | FDA UDI | Class II | Active |
| HELIOS III 532 Handpiece | HELIOS III 532 Handpiece | FDA UDI | Class II | Active |
| PALLAS Arm | PALLAS Arm | FDA UDI | Class II | Active |
| HELIOS 785 Pico 532 FX Handpiece | HELIOS 785 Pico 532 FX Handpiece | FDA UDI | Class II | Active |
| PicoLO User Manual | PicoLO User Manual(Rev. 2) | FDA UDI | Class II | Active |
| PicoLO 532 Handpiece | PicoLO 532 Handpiece | FDA UDI | Class II | Active |
| HELIOS IV 785 User Manual | HELIOS IV 785 User Manual | FDA UDI | Class II | Active |
| HELIOS Ⅲ body | HELIOS Ⅲ body | FDA UDI | Class II | Active |
| HELIOS 785 Pico User Manual | HELIOS 785 Pico (1754V2) User Manual | FDA UDI | Class II | Active |
| HELIOS Ⅲ Arm | HELIOS Ⅲ Arm | FDA UDI | Class II | Active |
| HELIOS 785 Pico 532 FX Handpiece | HELIOS 785 Pico (1754V2) 532 FX Handpiece | FDA UDI | Class II | Active |
| PALLAS 308/311 Solid-State UV Laser System | K191501 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.