The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Multipulse Hoplus.
| Device ID | K161257 |
| 510k Number | K161257 |
| Device Name: | MultiPulse HoPLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena, DE 07747 |
| Contact | Antje Katzer |
| Correspondent | Antje Katzer ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena, DE 07747 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-04 |
| Decision Date | 2017-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058784000460 | K161257 | 000 |
| 04058784000330 | K161257 | 000 |
| 04058784000323 | K161257 | 000 |
| 04058784000316 | K161257 | 000 |
| 04058784000309 | K161257 | 000 |
| 04058784000293 | K161257 | 000 |
| 04058784001009 | K161257 | 000 |
| 04058784000996 | K161257 | 000 |
| 04058784001054 | K161257 | 000 |
| 04058784000347 | K161257 | 000 |
| 04058784000354 | K161257 | 000 |
| 04058784000453 | K161257 | 000 |
| 04058784000446 | K161257 | 000 |
| 04058784000439 | K161257 | 000 |
| 04058784000422 | K161257 | 000 |
| 04058784000415 | K161257 | 000 |
| 04058784000408 | K161257 | 000 |
| 04058784000392 | K161257 | 000 |
| 04058784000361 | K161257 | 000 |
| 04058784001023 | K161257 | 000 |