The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Calculase Holmium Laser System And Accessories.
| Device ID | K052680 |
| 510k Number | K052680 |
| Device Name: | CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Paul S Lee |
| Correspondent | Paul S Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2006-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551074350 | K052680 | 000 |