Data / Medical devices / United States / Palette Life Sciences
Palette Life Sciences: FDA-registered device maker in Santa Barbara, CA, United States, 1 510(k) clearance and 2 PMA approvals
Palette Life Sciences is registered with the FDA (registration 3014909464) in Santa Barbara, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 2 PMA approvals under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014909464
- Address
- 27 East Cota Suite 402, Santa Barbara, CA, United States, 93101
- Owner or operator
- Palette Life Sciences (10058510)
- Roles
- Manufacturer
- First device listed
- October 5, 2018
- Registered through
- 2026
- Brand names listed
- Barrigel Injectable Gel, Deflux Injectable Gel, Solesta Injectable Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Bulking, Injectable For Gastro-Urology Use | LNM | 3 | Manufacturer | accessdata.fda.gov |
| Hydrogel Spacer | OVB | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 26, 2022 | K220641 | Barrigel Injectable Gel | OVB | Substantially Equivalent | Palette Life Sciences | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 27, 2011 | P100014 | SOLESTA INJECTABLE GEL | LNM | 33 | December 7, 2023 | accessdata.fda.gov |
| September 24, 2001 | P000029 | DEFLUX INJECTABLE GEL | LNM | 93 | May 31, 2024 | accessdata.fda.gov |
Compare with other makers
Updated December 7, 2023. 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.