ORION
by Pfizer Laser Systems 2 variants
510(k) K910152
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910152 | Date15 Apr 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Overview
AI-generated summary, 1 Oct 2026
ORION is a powered laser surgical instrument. It is classified under product code GEX and is intended for use in general and plastic surgery.
The device received FDA 510(k) clearance (K910152) on April 15, 1992, following a traditional review process. It was determined to be substantially equivalent to a predicate device. The manufacturer is Pfizer Laser Systems, located in Irvine, California.
Other devices from Pfizer Laser Systems
Questions
AI-generated answers, 1 Oct 2026
What is the ORION device intended for?
The ORION device is intended for use in general and plastic surgery as a powered laser surgical instrument, based on its FDA 510(k) clearance and product code GEX classification.
How was the ORION device cleared for market?
The ORION device received FDA 510(k) clearance (K910152) on April 15, 1992, through a traditional review process after being determined substantially equivalent to a predicate device.
Who manufactures the ORION device and where are they located?
The ORION device is manufactured by Pfizer Laser Systems, located at 3 Morgan, Irvine, California, 92718, United States, as listed in the FDA 510(k) submission.