# Home Skinovations, Ltd.

- Location (FDA's records): Yokneam, IL
- FDA decisions: 15 (2008–2023): 14 510(k) clearances and 1 De Novo grant
- Product codes: OHT (4), ILY (3), OHS (2), QMJ (2), GEX (2), NGX (1), OLP (1)
- 510(k) review time since 2016: median 136 days, against 119 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 26 (8 its own); citations of its devices by later devices: 36 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Photo Therapeutics Limited: 2 (https://510kreport.com/company/photo-therapeutics)
- Palomar Medical Technologies, Inc.: 2 (https://510kreport.com/company/palomar-medical-technologies)
- Spectragenics, Inc.: 2 (https://510kreport.com/company/spectragenics)
- Pharos Life Corporation: 2 (https://510kreport.com/company/pharos-life)
- Sport-Elec: 1 (https://510kreport.com/company/sport-elec)
- Quantum Devices, Inc.: 1 (https://510kreport.com/company/quantum-devices)
- H.V.R., Inc.: 1 (https://510kreport.com/company/hvr)
- Led Intellectual Properties, LLC: 1 (https://510kreport.com/company/led-intellectual-properties)

## Firms that cite its devices most
- El Global Trade, Ltd.: 5 (https://510kreport.com/company/el-global-trade)
- Shaser, Inc.: 2 (https://510kreport.com/company/shaser)
- Li-Tek Electronic Technology Corporation: 2 (https://510kreport.com/company/li-tek-electronic-technology)
- Syneron Medical, Ltd.: 2 (https://510kreport.com/company/syneron-medical)
- Cyden Limited: 2 (https://510kreport.com/company/cyden)
- Conair Corp.: 1 (https://510kreport.com/company/conair)
- Biorenew Labs, LLC: 1 (https://510kreport.com/company/biorenew-labs)
- Spectragenics, Inc.: 1 (https://510kreport.com/company/spectragenics)

## Its most-cited devices
- K121435: Silkn Blue (2013), cited by 8
- K103184: Silk'n Flash N GO (2010), cited by 7
- K082298: Flash N' GO (2008), cited by 6
- K110301: Silk'n FX (2011), cited by 4
- K131870: Glide Device (2013), cited by 3
- K120582: Heatlux (2012), cited by 2

## Recent decisions
- K214078: Silk’n Toothwave (Jan 13, 2023)
- DEN190039: ToothWave™ (Sep 17, 2020)
- K180279: Silk'n MODEL H5003 device (May 9, 2018)
- K171433: Silk'n Infinity (Aug 11, 2017)
- K162784: Silk'n HST (Mar 25, 2017)
- K152087: HeatLux Pro II (Jul 29, 2016)
- K150175: HeatLux Pro I (Mar 31, 2015)
- K141242: Glide Device (Oct 17, 2014)

Source page: https://510kreport.com/company/home-skinovations