FDA applicant
Lhasa Oms, Inc.
FDA records 8 decisions for Lhasa Oms, Inc. (Weymouth, MA) from 2005 to 2021: 8 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lhasa Oms, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lhasa Oms, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Lhasa”
FDA records each applicant name separately; these may or may not be the same firm.