Data / Medical devices / Israel / Active Optical Systems, Ltd./Efraim Bidas
Active Optical Systems, Ltd./Efraim Bidas: FDA-registered device maker in PETACH-TIKVA Central, Israel, 2 510(k) clearances
Active Optical Systems, Ltd./Efraim Bidas is registered with the FDA (registration 3005180774) in PETACH-TIKVA Central, Israel. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005180774
- Address
- 11 Shoham ST., PETACH-TIKVA Central, Israel, 49591
- Owner or operator
- ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS (9070935)
- Roles
- Manufacturer
- First device listed
- October 29, 2007
- Registered through
- 2026
- Brand names listed
- Body Shape RF-311N, Contour 360 Sheerwave, Crystal 512, Extra - 618, Extra - 818m, Extra 818, Forte - 718, Optima 518 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Epilator, High Frequency, Needle-Type | KCW | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 12, 2016 | K153718 | Spirit Hair Removal laser Family | GEX | Substantially Equivalent | Active Optical Systems , Ltd. | accessdata.fda.gov |
| April 29, 2005 | K050950 | MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS | GEX | Substantially Equivalent | Active Optical Systems, Ltd./Efraim Bidas | accessdata.fda.gov |
Compare with other makers
- All makers of Epilator, High Frequency, Needle-Type
- All makers of Powered Laser Surgical Instrument
- All makers of Exerciser, Powered
Updated February 12, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.