510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923438Substantially Equivalent

Boston Conditioning Solution

Polymer Technology Corp., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923438 is the FDA 510(k) clearance record for BOSTON CONDITIONING SOLUTION, a class II device, cleared for Polymer Technology Corp. on under FDA product code LPN (Accessories, Soft Lens Products). FDA records list 28 510(k) clearances for Polymer Technology Corp., from to . As of , FDA records show no recalls naming K923438.

Clearance record

Decision date
Received
(168 days to decision)
Product code
LPN Accessories, Soft Lens Products
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Polymer Technology Corp. 1400 N Goodman St., Rochester NY
510(k) summary
Statement
Third party review
No

Clearances, product code LPN

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