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Denlaser, Model 800

by Cao Group, Inc.

510(k) K003541

Denlaser, Model 800 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Cao Group, Inc., cleared under FDA 510(k) K003541 on 25 Jan 2001, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003541 Date25 Jan 2001ClearedStatusActive

Official records

Recalls

12 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0271-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0269-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0270-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0272-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541

    Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.

  • 7 recalls, same reason

    • Terminated Z-0249-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0250-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0247-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0246-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0251-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0252-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541
    • Terminated Z-0248-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541

    Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols)

    • Terminated Z-0273-2008 FDA Unclassified (pre-2012) initiated 23 Jul 2007 on shared 510(k) K003541

    Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-0270-2008
  2. Recall initiated FDA recalls Z-0249-2008
  3. Recall initiated FDA recalls Z-0250-2008
  4. Recall initiated FDA recalls Z-0247-2008
  5. Recall initiated FDA recalls Z-0246-2008
  6. Recall initiated FDA recalls Z-0273-2008
  7. Recall initiated FDA recalls Z-0251-2008
  8. Recall initiated FDA recalls Z-0252-2008
  9. Recall initiated FDA recalls Z-0272-2008
  10. Recall initiated FDA recalls Z-0248-2008

3 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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