The following data is part of a premarket notification filed by Endymion Medical Ltd with the FDA for Imagine Tc Skin Therapy System.
| Device ID | K083461 |
| 510k Number | K083461 |
| Device Name: | IMAGINE TC SKIN THERAPY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENDYMION MEDICAL LTD 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ENDYMION MEDICAL LTD 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016814224 | K083461 | 000 |
| 07290016814422 | K083461 | 000 |
| 07290016814439 | K083461 | 000 |
| 07290016814446 | K083461 | 000 |
| 07290016814453 | K083461 | 000 |
| 07290016814071 | K083461 | 000 |
| 07290016814101 | K083461 | 000 |
| 07290016814132 | K083461 | 000 |
| 07290016814149 | K083461 | 000 |
| 07290016814156 | K083461 | 000 |
| 07290016814163 | K083461 | 000 |
| 07290016814170 | K083461 | 000 |
| 07290016814187 | K083461 | 000 |
| 07290016814194 | K083461 | 000 |
| 07290016814408 | K083461 | 000 |