Chrysalis Intelligence · Sponsors · Palette Life Sciences

Palette Life Sciences

Santa Barbara, CA, US · 1 510(k) clearances · 24 PMAs

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Total clearances
1
2022-05-26 → 2022-05-26
Last 12 months
0
Product codes
1
Most recent
2022-05-26
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OVB Hydrogel Spacer Class II Radiology 1 2022-05-26
Class III

PMA approvals (24)

Total PMA records
24
Originals + supplements
Distinct product codes
1
First decision
2020-02-27
Most recent
2024-05-31
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2024-05-31 P000029-S098 Deflux® Injectable Gel Special (Immediate Track) LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2023-12-07 P100014-S035 Solesta® Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2023-12-07 P000029-S097 Deflux® Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2023-07-11 P100014-S034 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2023-07-11 P000029-S096 Deflux Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2022-03-22 P100014-S032 SOLESTA Injectable Gel 135 Review Track For 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2022-03-22 P000029-S094 DEFLUX Injectable Gel 135 Review Track For 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2022-03-17 P100014-S033 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2022-03-17 P000029-S095 DEFLUX Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2021-10-27 P100014-S031 Solesta (Injectable Gel) Normal 180 Day Track No User Fee LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2021-05-03 P100014-S024 Solesta Injectable Gel 135 Review Track For 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2021-05-03 P000029-S087 DEFLUX Injectable Gel 135 Review Track For 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-12-18 P100014-S030 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-12-18 P000029-S093 DEFLUX Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-12-11 P100014-S029 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-12-11 P000029-S092 DEFLUX Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-11-18 P000029-S091 Deflux Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-11-12 P100014-S028 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-11-12 P000029-S090 Deflux Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-10-09 P100014-S026 Solesta Injectable Gel Normal 180 Day Track No User Fee LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-07-09 P100014-S027 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-07-09 P000029-S089 DEFLUX Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-02-27 P100014-S025 Solesta Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
2020-02-27 P000029-S088 DEFLUX Injectable Gel 30-Day Notice LNM Agent, Bulking, Injectable For Gastro-Urology Use Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-05-26 K220641 Barrigel Injectable Gel OVB Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence