The following data is part of a premarket notification filed by Omm Imports Inc Dba Zero Gravity with the FDA for Perfectio Led Infrared Device.
| Device ID | K152332 |
| 510k Number | K152332 |
| Device Name: | Perfectio LED Infrared Device |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | OMM IMPORTS INC DBA ZERO GRAVITY 1945 S OCEAN DR APT 509 HALLANDLE BEACH BLVD Hallandle, FL 33009 |
| Contact | Ohad Menachem |
| Correspondent | Doris Dong SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706, NO 128 SONGLE RD., SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-18 |
| Decision Date | 2016-02-25 |
| Summary: | summary |