Dreamcon Co., Ltd. FDA Record
Dreamcon Co., Ltd. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Dreamcon Co., Ltd." is on file.
- Latest inspection
- May 11, 2023 · VAI
- Latest 510(k)
- Jun 17, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 11, 2023 | Yangsan, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3010460316 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010460316 | Yangsan, Korea (The Republic Of) | 1 | May 11, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K123431 | DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT… | Jun 17, 2013 |
Dreamcon Co., Ltd. and the FDA: common questions
Has Dreamcon Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Dreamcon Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Dreamcon Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Dreamcon Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Dreamcon Co., Ltd.?
The most recent FDA inspection on file ended May 11, 2023 at Yangsan, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Dreamcon Co., Ltd. on file.
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