Home Skinovations , Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Home Skinovations , Ltd.” (first 2008, latest 2023), plus 1 De Novo decision, across 7 product codes in 3 review panels. Median 510(k) review time under this name: 117 days. Since 2017 the median was 136 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 130 |
| 2013 | 2 | 168 |
| 2014 | 1 | 156 |
| 2015 | 1 | 64 |
| 2016 | 1 | 368 |
| 2017 | 2 | 130 |
| 2018 | 1 | 98 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 382 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Home Skinovations , Ltd. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 4 | 4 |
| ILY | Lamp, Infrared, Therapeutic Heating | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 2 | 2 |
| QMJ | Powered Radiofrequency Toothbrush | 2 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
Most recent Home Skinovations , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K214078 | Silkn Toothwave | QMJ | 2023-01-13 | 382 |
| K180279 | Silk'n MODEL H5003 device | NGX | 2018-05-09 | 98 |
| K171433 | Silk'n Infinity | OHT | 2017-08-11 | 88 |
| K162784 | Silk'n HST | OHS | 2017-03-25 | 173 |
| K152087 | HeatLux Pro II | ILY | 2016-07-29 | 368 |
| K150175 | HeatLux Pro I | ILY | 2015-03-31 | 64 |
| K141242 | GLIDE DEVICE | OHT | 2014-10-17 | 156 |
| K131870 | GLIDE DEVICE | OHT | 2013-08-14 | 51 |
| K121435 | SILKN BLUE | OLP | 2013-02-22 | 284 |
| K120582 | HEATLUX | ILY | 2012-07-06 | 130 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190039 | De Novo | Powered Radiofrequency Toothbrush | 2020-09-17 |
Recalls
openFDA lists no recalls under a recalling firm named Home Skinovations , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Home Skinovations , Ltd. is the lead sponsor of 11 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04596761: ToothWave Calculus Reduction and Accumulation Prevention Study (Completed, started 2020-07-15)
- NCT04092075: Safety and Efficacy of the ToothWave -12 Weeks Calculus Study (Completed, started 2019-08-07)
- NCT04092062: Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas) (Completed, started 2019-08-07)
- NCT04023097: Self-selection Study of the Toothwave Toothbrush (Completed, started 2019-07-02)
- NCT03885609: Safety and Efficacy of the ToothWave Power Toothbrush for Extrinsic Stain Reduction (Completed, started 2019-02-28)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Home Diagnostics, Inc. (22 510(k)s)
- Home Care Technology Co., Ltd. (4 510(k)s)
- Home Medical Services (4 510(k)s)
- Home Access Health Corp. (2 510(k)s)
- Home Dialysis Plus (2 510(k)s)
- Home Health Technology Co., Ltd. (2 510(k)s)
- Home Healthcare Products, Inc. (2 510(k)s)
- Home Well Trading, Ltd. (2 510(k)s)
- Home Wellness West (2 510(k)s)
- Home Care Instruments, Inc. (1 510(k)s)
- Home Dental Care, Inc. (1 510(k)s)
- Home Medical Mfg., Co., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Home Skinovations , Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Home Skinovations , Ltd.” (first 2008, latest 2023), plus 1 De Novo decision, across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Home Skinovations , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Home Skinovations , Ltd. is 117 days. Since 2017: 136 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Home Skinovations , Ltd.?
The most frequent FDA product codes under this applicant name are OHT (Light Based Over-The-Counter Hair Removal, 4); ILY (Lamp, Infrared, Therapeutic Heating, 3); GEX (Powered Laser Surgical Instrument, 2).
Next steps
- See all 14 Home Skinovations , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OHT, Home Skinovations , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.