FDA-recognized standard · Radiology
IEC 60601-2-57: Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring cosmetic and aesthetic use
Yes. FDA recognizes IEC 60601-2-57 Edition 2.0 2023-07 as recognition 12-355, entered 2024-05-29. FDA also lists IEC 60601-2-57 Edition 1.0 2011-01 (recognition 12-242, transition period ending 2027-07-04).
Recognized editions of IEC 60601-2-57
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 12-355 | IEC 60601-2-57 Edition 2.0 2023-07 | 2024-05-29 | Complete | — |
| 12-242 | IEC 60601-2-57 Edition 1.0 2011-01 | 2012-03-16 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against IEC 60601-2-57: 21 CFR 878.4810, 21 CFR 878.5400, 21 CFR 890.5500.
Product codes that cite IEC 60601-2-57
6 FDA product codes cite IEC 60601-2-57, including MVF, NHN, OLI, ONE, ONF.
- MVF
- NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- OLI Fat Reducing Low Level Laser
- ONE
- ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
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.