Home / 510(k) Clearances / K221275

510(k) K221275

Qraycam PRO by AIOBIO Co., Ltd. — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2024
Date Received
May 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

Other clearances by AIOBIO Co., Ltd.

  • K183121 — Qraypen (July 18, 2019)

Other clearances for product code NBL

  • K242103 — TRIOS Ready Tip (April 4, 2025)
  • K231722 — SmarTooth (May 1, 2024)
  • K223470 — C50 (December 14, 2023)
  • K221249 — L1P-1F (TRIOS 5) (September 16, 2022)
  • K183471 — IC-WHCD100 (Inspire) (July 2, 2020)
  • K171007 — Fluorescence Mode (May 3, 2018)
  • K170822 — Electronic Caries Detector (September 11, 2017)
  • K150672 — VistaCam iX Proof (January 27, 2016)
  • K121685 — SOPROCARE (March 12, 2013)
  • K112139 — THE CANARY SYSTEM (October 26, 2012)