Data / Medical devices / United States / Hai Laboratories, Inc.
Hai Laboratories, Inc.: FDA-registered device maker in Lexington, MA, United States, 3 510(k) clearances
Hai Laboratories, Inc. is registered with the FDA (registration 1226587) in Lexington, MA, United States. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 29, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226587
- FEI number
- 3003046678
- Address
- 320 Massachusetts Ave, Lexington, MA, United States, 02420
- Owner or operator
- HAI LABORATORIES, INC. (9040002)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 29, 2001
- Registered through
- 2026
- Brand names listed
- AB-6100, AB-6200, CL-1000eva, CL-1000nc, CL-1000xyz, Capsule Hook, Capsulorhexis Forceps, Capsulotomy Forceps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Manufacturer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spoon, Ophthalmic | HNB | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2007 | K063433 | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 | IYO | Substantially Equivalent | Meda , Ltd. | accessdata.fda.gov |
| December 4, 2003 | K033190 | VISION-TECH YZ SLIT LAMP, MODEL 66 | HJO | Substantially Equivalent | Suzhou 66 Vision-Tech Co., Ltd. | accessdata.fda.gov |
| September 20, 2000 | K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | HLI | Substantially Equivalent | Hai Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Biomicroscope, Slit-Lamp, Ac-Powered
- All makers of Caliper, Ophthalmic
- All makers of Hook, Ophthalmic
- All makers of Ophthalmoscope, Ac-Powered
- All makers of Spatula, Ophthalmic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated January 29, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.