Synemed, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Synemed, Inc. makes
Synemed, Inc. manufactures ophthalmic and dermatological devices including laser systems such as the PICOLAS Neodymium-YAG ophthalmic laser and OPTHALAS photocouagulator, vacuum-based curettage systems like the SYNEVAC vacuum curettage systems and SYNEVAC vacuum source unit, and handheld or modular instruments such as the DERMATOLOGY HANDPIECE-OPHTH LASER, MODEL 200 SQUID, SCOPE MASTER, THE FIELDMASTER MODEL 275, and FIELD TREND.
The company's devices span Class I, Class II, and Class III classifications and are listed in the FDA’s 510(k) and PMA registries. Synemed, Inc. is based in the United States.
Catalogue
Dermatology Handpiece-Ophth Laser Ref K833274
510(k) 510(k)Model 200 Squid Ref K822853
510(k) 510(k)Scope Master Ref K811270
510(k) 510(k)Synevac Vacuum Curettage Systems Ref K813282
510(k) 510(k)Opthalas Photocoagulator Ref K828585
510(k) 510(k)Synevac Vacuum Source Unit Ref K831085
510(k) 510(k)The Fieldmaster Model 275 Ref K852936
510(k) 510(k)Field Trend Ref K954037
510(k) 510(k)Picolas Neodymiun-Yag Ophthalmic Laseer Ref P830080
PMA PMA
Frequently asked questions
How many devices does Synemed, Inc. have in the registry?
The registry currently lists 9 devices for Synemed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synemed, Inc.'s devices?
Among its 9 most recently registered devices, Synemed, Inc. has devices listed in FDA 510(k) (8 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Synemed, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Synemed, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Synemed, Inc. in the registry?
The most recently registered devices listed for Synemed, Inc. include DERMATOLOGY HANDPIECE-OPHTH LASER, MODEL 200 SQUID, SCOPE MASTER and SYNEVAC VACUUM CURETTAGE SYSTEMS.