The following data is part of a premarket notification filed by Home Well Trading Ltd with the FDA for Beurer Ipl 5500 Device/ Ipl 5000/ Ipl Pureskin Pro.
| Device ID | K181121 |
| 510k Number | K181121 |
| Device Name: | Beurer IPL 5500 Device/ IPL 5000/ IPL PureSkin Pro |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Home Well Trading LTD Omar Hodge Building, Road Town Tortola, VG 1110 |
| Contact | Martin Gurovich |
| Correspondent | Martin Gurovich Home Well Trading LTD Omar Hodge Building, Road Town Tortola, VG 1110 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-06-28 |
| Summary: | summary |