510(k) Report

FDA applicant

Ids, Ltd.

Seoul, KR6 decisions1994–20231 recall

FDA records 6 decisions for Ids, Ltd. (Seoul, KR) from 1994 to 2023: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and CEW (Radioimmunoassay, Parathyroid Hormone). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “I.D.S.”, “Ids, Limited”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Ids, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2017: 12018: 22023: 2
2007high 2 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ids, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ids, Ltd.’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) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions
  • CEWRadioimmunoassay, Parathyroid Hormone1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 112 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 20232cite it
  • K181868SHINY RPL SystemIds, Ltd. · 20181cites it
  • K180036SMAXEL CO2 Surgical Laser SystemIds, Ltd. · 20181cites it

What has FDA decided for it lately?

  • K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023
  • K222485SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG LaserIds, Limited · 2023
  • K181868SHINY RPL SystemIds, Ltd. · 2018
  • K180036SMAXEL CO2 Surgical Laser SystemIds, Ltd. · 20181 recall
  • K171079Q-Switched Nd:YAG Laser SystemIds, Ltd. · 2017
  • K941878Octeia Intact PTHI.D.S. · 1994

All 4 as Ids, Ltd. →The one decision as I.D.S. →The one decision as Ids, Limited →

What has been recalled?

1 recall linked to its devices; the latest:

  • K180036Smaxel Fractional CO2 Laser, a Class IV medical laser system.Oct 16, 2024Class II