The following data is part of a premarket notification filed by Oberon Gmbh Fiber Technologies with the FDA for Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber.
| Device ID | K140470 |
| 510k Number | K140470 |
| Device Name: | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OBERON GMBH FIBER TECHNOLOGIES 7404 W. DETROIT STREET, STE 140 Chandler, AZ 85226 |
| Contact | Armin Kaus |
| Correspondent | Armin Kaus OBERON GMBH FIBER TECHNOLOGIES 7404 W. DETROIT STREET, STE 140 Chandler, AZ 85226 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-25 |
| Decision Date | 2014-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EOBN270120S0 | K140470 | 000 |
| EOBN200029S0 | K140470 | 000 |
| EOBN220126S0 | K140470 | 000 |
| EOBN210167S0 | K140470 | 000 |
| EOBN270123S0 | K140470 | 000 |
| EOBN270122S0 | K140470 | 000 |
| EOBN210138S0 | K140470 | 000 |
| EOBN210137S0 | K140470 | 000 |
| EOBN210136S0 | K140470 | 000 |
| EOBN210135S0 | K140470 | 000 |
| EOBN220138S0 | K140470 | 000 |
| EOBN270518S0 | K140470 | 000 |
| EOBN270192S0 | K140470 | 000 |
| EOBN270191S0 | K140470 | 000 |
| EOBN270190S0 | K140470 | 000 |
| EOBN210181S0 | K140470 | 000 |
| EOBN210180S0 | K140470 | 000 |
| EOBN210110S0 | K140470 | 000 |
| EOBN210111S0 | K140470 | 000 |
| EOBN210112S0 | K140470 | 000 |
| EOBN270119S0 | K140470 | 000 |
| EOBN270118S0 | K140470 | 000 |
| EOBN270117S0 | K140470 | 000 |
| EOBN270082S0 | K140470 | 000 |
| EOBN270055S0 | K140470 | 000 |
| EOBN270029S0 | K140470 | 000 |
| EOBN230053S0 | K140470 | 000 |
| EOBN230052N0 | K140470 | 000 |
| EOBN230051N0 | K140470 | 000 |
| EOBN230031S0 | K140470 | 000 |
| EOBN220051S0 | K140470 | 000 |
| EOBN210117S0 | K140470 | 000 |
| EOBN210116S0 | K140470 | 000 |
| EOBN210115S0 | K140470 | 000 |
| EOBN210114S0 | K140470 | 000 |
| EOBN210113S0 | K140470 | 000 |
| EOBN220105S0 | K140470 | 000 |