FDA-recognized standard · Radiology
IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
Yes. FDA recognizes IEC 60825-1 Edition 2.0 2007-03 as recognition 12-273, entered 2014-07-09.
Recognized editions of IEC 60825-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-273 | IEC 60825-1 Edition 2.0 2007-03 | 2014-07-09 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 60825-1: 21 CFR 874.4490, 21 CFR 874.4500, 21 CFR 878.4810, 21 CFR 884.4550, 21 CFR 886.4390, 21 CFR 886.4392, 21 CFR 886.4670, 21 CFR 886.4690.
Product codes that cite IEC 60825-1
21 FDA product codes cite IEC 60825-1, including EWG, GEX, HHR, HQB, HQF.
- EWG
- GEX Powered Laser Surgical Instrument
- HHR
- HQB
- HQF Laser, Ophthalmic
- LKW
- LLF
- LLO
- LLW
- LMS
- LNK
- LOI
- LPC
- LWX
- LXR
- LXS
- LZS
- MNO
- MVF
- MVG
- MXO
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.