The following data is part of a premarket notification filed by I-tech Industries Srl with the FDA for Icoone H (also Referred To As Icoone Laser And Icoone –h Laser).
| Device ID | K182453 |
| 510k Number | K182453 |
| Device Name: | ICOONE H (also Referred To As ICOONE LASER And ICOONE –h LASER) |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | I-TECH INDUSTRIES SRL Via Cicogna 34/b San Lazzaro Di Savena, IT 40068 |
| Contact | Paolo Abbreviato |
| Correspondent | Jay Mansour Mansour Consulting LLC 845 Aronson Lake Court Roswell, GA 30075 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2019-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18057592610246 | K182453 | 000 |