Data / Medical devices / United States / Joylux, Inc.
Joylux, Inc.: FDA-registered device maker in Seattle, WA, United States, 2 510(k) clearances
Joylux, Inc. is registered with the FDA (registration 3012262584) in Seattle, WA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012262584
- Address
- 5628 Airport Way S Ste 210, Seattle, WA, United States, 98108
- Owner or operator
- Joylux, Inc. (10087681)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 4, 2023
- Registered through
- 2026
- Brand names listed
- ColdHER, ILYEO body, JUICY LIKE A PEACH, Joylux Intimacy Gel, Let's Spin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2025 | K242958 | Joylux Intimacy Gel (PG3100) | NUC | Substantially Equivalent | Joylux, Inc. | accessdata.fda.gov |
| November 10, 2020 | K200098 | VagiVital Aktivgel | NUC | Substantially Equivalent | Peptonic Medical AB | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Lubricant, Personal
Updated March 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.