The following data is part of a premarket notification filed by Clareblend, Inc. with the FDA for Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830.
| Device ID | K073022 |
| 510k Number | K073022 |
| Device Name: | CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLAREBLEND, INC. 675 PINE STREET Elgin, IL 60123 |
| Contact | Jill Creasy |
| Correspondent | Jill Creasy CLAREBLEND, INC. 675 PINE STREET Elgin, IL 60123 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-26 |
| Decision Date | 2008-10-01 |
| Summary: | summary |