510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BOSTON FOUNDATION for SIGHT/BostonSight TECH

Needham Hgts, MA, US

BOSTON FOUNDATION FOR SIGHT/BostonSight TECH appears in FDA device records in Needham Hgts, MA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to BOSTON FOUNDATION for SIGHT/BostonSight TECH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Boston Foundation For Sight510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for BOSTON FOUNDATION for SIGHT/BostonSight TECH in 2016.

Clearances by year, as a table
510(k) clearance decisions for BOSTON FOUNDATION for SIGHT/BostonSight TECH, by decision year
YearClearances
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensHQDSubstantially Equivalent

Registered establishments

FDA registered establishments for BOSTON FOUNDATION for SIGHT/BostonSight TECH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30062049133006204913BOSTON FOUNDATION FOR SIGHT/BostonSight TECH464 Hillside Avenue, Needham Hgts, MA 02494 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2191-2025BostonSight PROSE Lens.Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.Class IIOpen, Classified
Z-2190-2025BostonSight SCLERAL LensSelect orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain