Facility
IDS LTD
2 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3034246188 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | RM.914, 915, SJ Techno Ville, 278, Beotkkot-ro, Geumcheon-gu, Seoul, 08511, KOREA Geumcheon-gu Seoul, KR 08511 |
| Registration status | Active · expires 2026 |
| Parent company | IDS LTD (owner-operator 10053355) |
| Brand names | Q10 Q-Switched Nd:YAG Laser System |
Devices registered here (1)
- Powered Laser Surgical InstrumentProduct code GEX · Class II · General, Plastic Surgery · 21 CFR 878.4810
Recalls & enforcement
- Class IIOngoing2024-10-16The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
- Class IITerminated2012-11-07Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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