Data / Medical devices / United States / BostonSight/BostonSight Specialty Lenses/BostonSight TECH
BostonSight/BostonSight Specialty Lenses/BostonSight TECH: FDA-registered device maker in Needham Hgts, MA, United States, 1 510(k) clearance
BostonSight/BostonSight Specialty Lenses/BostonSight TECH is registered with the FDA (registration 3006204913) in Needham Hgts, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006204913
- Address
- 464 Hillside Avenue Suite 205, Needham Hgts, MA, United States, 02494
- Owner or operator
- BostonSight (10027307)
- Roles
- Manufacturer
- First device listed
- March 13, 2026
- Registered through
- 2027
- Brand names listed
- BostonSight PROSE, BostonSight SCLERAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | 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 |
|---|---|---|---|---|---|---|
| August 14, 2024 | K241571 | BostonSight® Specialty Lenses | HQD | Substantially Equivalent | Boston Foundation For Sight, Inc. D/B/A Bostonsight | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2025 | 97123 | Class II | Completed | BostonSight SCLERAL Lens | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | accessdata.fda.gov |
Compare with other makers
Updated July 29, 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.