Home Skinovations, Ltd.
Yokneam, IL
Home Skinovations , Ltd. appears in FDA device records in Yokneam, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Home Skinovations, Ltd. between 2008 and 2023. The busiest year on record is 2008, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K214078 | Silk’n Toothwave | QMJ | Substantially Equivalent | |
| DEN190039 | ToothWave™ | QMJ | Unknown | |
| K180279 | Silk'n MODEL H5003 device | NGX | Substantially Equivalent | |
| K171433 | Silk'n Infinity | OHT | Substantially Equivalent | |
| K162784 | Silk'n HST | OHS | Substantially Equivalent | |
| K152087 | HeatLux Pro II | ILY | Substantially Equivalent | |
| K150175 | HeatLux Pro I | ILY | Substantially Equivalent | |
| K141242 | GLIDE DEVICE | OHT | Substantially Equivalent | |
| K131870 | GLIDE DEVICE | OHT | Substantially Equivalent | |
| K121435 | SILKN BLUE | OLP | Substantially Equivalent | |
| K120582 | HEATLUX | ILY | Substantially Equivalent | |
| K110301 | SILK'N FX | OHS | Substantially Equivalent | |
| K103184 | SILK'N FLASH N GO | OHT | Substantially Equivalent | |
| K082298 | FLASH N' GO | GEX | Substantially Equivalent | |
| K072906 | SILK'N | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- ILYLamp, Infrared, Therapeutic Heating
- OHSLight Based Over The Counter Wrinkle Reduction
- OHTLight Based Over-The-Counter Hair Removal
- OLPOver-The-Counter Powered Light Based Laser For Acne
- GEXPowered Laser Surgical Instrument
- QMJPowered Radiofrequency Toothbrush
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain