IDS LTD
FDA Regulatory Profile
IDS LTD has 1 FDA recall, 3 inspections, 5 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0804-2025 · Class II · Oct 16, 2024
- Latest inspection
- Aug 23, 2024 · OAI
- Latest 510(k)
- Dec 21, 2023
Reviewing IDS LTD as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Request a free FDA snapshot
Or get IDS LTD's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 5 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 3 | Oct 26, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
I.D.S
Same company group | 0 | 1 | 0 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0804-2025 | Class II | Smaxel Fractional CO2 Laser, a Class IV medical laser system. | Oct 16, 2024 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 23, 2024 | Paju, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3012639861 |
| Nov 8, 2019 | Kumamoto, Japan | Devices | Voluntary Action Indicated (VAI) | 3005655287 |
| Apr 6, 2017 | Kumamoto, Japan | Devices | Voluntary Action Indicated (VAI) | 3005655287 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233018 | PICOSECOND Nd:YAG Laser System | Dec 21, 2023 |
| K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser | Mar 29, 2023 |
| K181868 | SHINY RPL System | Oct 5, 2018 |
| K180036 | SMAXEL CO2 Surgical Laser System | Feb 2, 2018 |
| K171079 | Q-Switched Nd:YAG Laser System | Aug 1, 2017 |