The following data is part of a premarket notification filed by Kelsey, Inc. with the FDA for Kelsey Intersitital Laser Therapy System.
| Device ID | K070353 |
| 510k Number | K070353 |
| Device Name: | KELSEY INTERSITITAL LASER THERAPY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KELSEY, INC. 303 PATLEIGH RD Catonsville, MD 21228 |
| Contact | Paul Ketteridge |
| Correspondent | Paul Ketteridge KELSEY, INC. 303 PATLEIGH RD Catonsville, MD 21228 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-05-02 |
| Summary: | summary |