The following data is part of a premarket notification filed by Ophthalmed Llc with the FDA for Ophthalmed Bending Laser Probes.
| Device ID | K142830 |
| 510k Number | K142830 |
| Device Name: | Ophthalmed Bending Laser Probes |
| Classification | Laser, Ophthalmic |
| Applicant | OPHTHALMED LLC 1050 Northfield Ct Ste 280 Roswell, GA 30076 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour OPHTHALMED LLC 1050 Northfield Ct Ste 280 Roswell, GA 30076 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M735A5026005 | K142830 | 000 |
| M735B5026035 | K142830 | 000 |
| M735B5026045 | K142830 | 000 |
| M735B5027035 | K142830 | 000 |
| M735B5027045 | K142830 | 000 |
| M735B5036035 | K142830 | 000 |
| M735B5036045 | K142830 | 000 |
| M735B5037035 | K142830 | 000 |
| M735B5037045 | K142830 | 000 |
| M735B5076035 | K142830 | 000 |
| M735B5076045 | K142830 | 000 |
| M735A50B7005 | K142830 | 000 |
| M735A50B6005 | K142830 | 000 |
| M735A50A7005 | K142830 | 000 |
| M735A5027005 | K142830 | 000 |
| M735A5036005 | K142830 | 000 |
| M735A5037005 | K142830 | 000 |
| M735A5076005 | K142830 | 000 |
| M735A5077005 | K142830 | 000 |
| M735A5086005 | K142830 | 000 |
| M735A5087005 | K142830 | 000 |
| M735A5096005 | K142830 | 000 |
| M735A5097005 | K142830 | 000 |
| M735A50A6005 | K142830 | 000 |
| M735B5077035 | K142830 | 000 |
| M735B5077045 | K142830 | 000 |
| M735B50B6045 | K142830 | 000 |
| M735B50B7035 | K142830 | 000 |
| M735B50B7045 | K142830 | 000 |
| M735T2020005 | K142830 | 000 |
| M735B5072055 | K142830 | 000 |
| M735B5073055 | K142830 | 000 |
| B384VS014020A5 | K142830 | 000 |
| B384VS014023A5 | K142830 | 000 |
| B384VS014023I5 | K142830 | 000 |
| B384VS014025A5 | K142830 | 000 |
| M735B50B6035 | K142830 | 000 |
| M735B50A7045 | K142830 | 000 |
| M735B50A7035 | K142830 | 000 |
| M735B5086035 | K142830 | 000 |
| M735B5086045 | K142830 | 000 |
| M735B5087035 | K142830 | 000 |
| M735B5087045 | K142830 | 000 |
| M735B5096035 | K142830 | 000 |
| M735B5096045 | K142830 | 000 |
| M735B5097035 | K142830 | 000 |
| M735B5097045 | K142830 | 000 |
| M735B50A6035 | K142830 | 000 |
| M735B50A6045 | K142830 | 000 |
| B384VS014025I5 | K142830 | 000 |