Curelight, Ltd.
Country not established
- Devices
- 6
What Curelight, Ltd. makes
Curelight, Ltd. manufactures phototherapy systems designed for medical treatments, including the ICLEAR, RECLEAR, MULTICLEAR, CLEARLIGHT, and CLEAR100 series. These devices use targeted light therapy for conditions such as corneal haze, refractive surgery recovery, and ocular surface disorders. The MULTICLEAR and MULTICLEAR XL models incorporate multiwavelength capabilities for broader therapeutic applications.
The company’s phototherapy systems fall under FDA Class II devices and are authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry. Curelight, Ltd. is based in the United States.
Catalogue
Iclear Phototherapy System, Model FGCM0002 Ref K030338
510(k) 510(k)Reclear Phototherapy System, Model FGCM0012 Ref K033183
510(k) 510(k)- 510(k) 510(k)
Clearlight Phototheraphy System, Model Cl 420 Ref K013623
510(k) 510(k)CLEAR100 Phototherapy System, Model FGCM0002 Ref K041569
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Curelight, Ltd. have in the registry?
The registry currently lists 6 devices for Curelight, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Curelight, Ltd.'s devices?
Among its 6 most recently registered devices, Curelight, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Curelight, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Curelight, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Curelight, Ltd. in the registry?
The most recently registered devices listed for Curelight, Ltd. include ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002, RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012, MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM and CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420.