The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for International Biophysics Corporation (ibc) Laser Peel System.
| Device ID | K030181 |
| 510k Number | K030181 |
| Device Name: | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Contact | Len Hickey |
| Correspondent | Len Hickey INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-17 |
| Decision Date | 2003-04-17 |