Intl. Solarium Manufacturer, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Intl. Solarium Manufacturer, Inc. makes
The company manufactures ultraviolet (UV) phototherapy devices, including the I.S.M. PRODUCT FAMILY models (P2400C, A, ABC, and R3600C) for medical skin treatments, as well as a CO₂ surgical laser system (FLEXUS 2) for precision tissue ablation.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records in the U.S. registry. The manufacturer is based in the United States.
Catalogue
I.S.M. Product Family Model P2400C, A & Abc Ref K854171
Regimes: 510(k) Registry: 510(k)Flexus 2 CO2 Surgical Laser System Ref K850985
Regimes: 510(k) Registry: 510(k)I.S.M. Product Family Model R3600C Ref K854170
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intl. Solarium Manufacturer, Inc. have in the registry?
The registry currently lists 3 devices for Intl. Solarium Manufacturer, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intl. Solarium Manufacturer, Inc.'s devices?
Among its 3 most recently registered devices, Intl. Solarium Manufacturer, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Intl. Solarium Manufacturer, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Intl. Solarium Manufacturer, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intl. Solarium Manufacturer, Inc. in the registry?
The most recently registered devices listed for Intl. Solarium Manufacturer, Inc. include I.S.M. PRODUCT FAMILY MODEL P2400C, A & ABC, FLEXUS 2 CO2 SURGICAL LASER SYSTEM and I.S.M. PRODUCT FAMILY MODEL R3600C.