Laser - 1000

510(k) K882436

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK882436	Date4 Aug 1988Cleared	StatusActive

3 recalls · FDA

- Terminated Z-0517-2018 FDA Class II initiated 14 Jul 2017
The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
- Terminated Z-0016-2017 FDA Class II initiated 19 Aug 2016
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
- Terminated Z-2538-2015 FDA Class II initiated 4 Jun 2015
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.

1 jurisdiction

United States — FDA 510(k) Active

510(k)