510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130051Unknown

Pediatric Vision Scanner

Rebiscan, Inc., Cambridge MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130051 is the FDA 510(k) clearance record for PEDIATRIC VISION SCANNER, a class II device, cleared for Rebiscan, Inc. on under FDA product code PMW (Strabismus Detection Device). FDA's definition for product code PMW reads: "For the automated detection of misalignment of the visual axes for prescription use only". FDA records list one 510(k) clearance for Rebiscan, Inc. As of , FDA records show no recalls naming DEN130051.

Clearance record

Decision date
Received
(908 days to decision)
Product code
PMW Strabismus Detection Device
Regulation
21 CFR 886.1342
Device class
Class II
Review panel
Ophthalmic
Applicant
Rebiscan, Inc. 30 Mount Auburn St., Suite B, Cambridge MA
Third party review
No

Clearances, product code PMW

Trailing 12 months

FDA records hold no clearances under product code PMW in the trailing twelve months.

FDA records show no clearances under product code PMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PMW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260