510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K161461Substantially Equivalent

BostonSight PD Prosthetic Device

Bostonsight, Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161461 is the FDA 510(k) clearance record for BostonSight PD Prosthetic Device, a class II device, cleared for Bostonsight on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list 2 510(k) clearances for Bostonsight, from to . As of , FDA records show one recall naming K161461.

Clearance record

Decision date
Received
(60 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Bostonsight 464 Hillside Ave., Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQD

Trailing 12 months
1 clearance under product code HQD in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260