Data / Medical devices / United States / Pearl Inc.
Pearl Inc.: FDA-registered device maker in West Hollywood, CA, United States, 8 510(k) clearances
Pearl Inc. is registered with the FDA (registration 3021887566) in West Hollywood, CA, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021887566
- Address
- 9200 W Sunset Blvd Ste 430, West Hollywood, CA, United States, 90069
- Owner or operator
- Pearl Inc. (10084584)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 9, 2022
- Registered through
- 2026
- Brand names listed
- Second Opinion, Second Opinion 3D, Second Opinion BLE, Second Opinion CC, Second Opinion CS, Second Opinion Panoramic, Second Opinion Pediatric, Second Opinion Periapical Radiolucency Contours
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 14, 2025 | K250525 | Second Opinion® Panoramic | MYN | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| June 12, 2025 | K243234 | Second Opinion® CS | MYN | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| May 23, 2025 | K243989 | Second Opinion® 3D | QIH | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| May 9, 2025 | K243230 | Second Opinion® BLE | QIH | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| May 5, 2025 | K243893 | Second Opinion® Pediatric | MYN | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| April 11, 2025 | K242600 | Second Opinion Periapical Radiolucency Contours | MYN | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| January 16, 2025 | K242522 | Second Opinion CC | MYN | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
| March 4, 2022 | K210365 | Second Opinion | MYN | Substantially Equivalent | Pearl, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 14, 2025. 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.