Certifications / Regulatory Compliance Status
FDA (Food and Drug Administration), United States
For photoelectric sensors, the FDA establishes radiation safety performance standards that manufacturers must meet for laser products to be legally sold in the U.S. market, and laser products exported to the United States must comply with the FDA’s laser regulations.
Under Sections 201(h) and 531(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), laser products may be defined as medical devices or electronic products, respectively.
Such products are subject to the provisions of the FD&C Act and its implementing regulations applicable to medical devices.
Photoelectric Sensors
| Series | Laser CLASS＊1 | Accession Number | FDA technical standards |
|---|---|---|---|
| BGS-DL*2 *4 | CLASS 2 | 1710689 | Laser Notice No.56 |
| BGS-HL/-HDL | CLASS 1 | 1611062 | Laser Notice No.56 |
| BGS-HL/-HDL | CLASS 2 | 1611061 | Laser Notice No.56 |
| BGS-ZL | CLASS 1 | 0312307 | CFR |
| DR-Q special order products | CLASS 1 | 1710688 | Laser Notice No.56 |
| DR-Q | CLASS 2 | 1710689 | Laser Notice No.56 |
| DS sensor head | CLASS 2 | 0312307 | CFR |
| DS sensor heads, thru-beam emitter |
CLASS 1 | 1910207 | CFR |
| TOF-3V | CLASS 1 | 1910782 | Laser Notice No.56 |
| TOF-L/-DL | CLASS 1 | 1611159 | Laser Notice No.56 |
| Z-L | CLASS 2 | 0312307 | CFR |
| Z-L emitter | CLASS 1 | 1811174 | CFR |
Displacement Sensors
| Series | Laser CLASS＊1 | Accession Number | FDA technical standards |
|---|---|---|---|
| CD22 | CLASS 1 | 1611062 | Laser Notice No.56 |
| CD22 | CLASS 2 | 1611061 | Laser Notice No.56 |
| CD2H | CLASS 1 | 2111790 | Laser Notice No.56 |
| CD2H | CLASS 2 | 2111791 | Laser Notice No.56 |
| CD2S | CLASS 1 | 2510542 | Laser Notice No.56 |
| CD33 | CLASS 2 | 2011591 | CFR |
| CD4＊4 | CLASS 1、2、3R | 0312307 | CFR |
| CD5 | CLASS 1、2、3R | 0312307 | CFR |
| CDX | CLASS 1 | 1710374 | Laser Notice No.56 |
| LS | CLASS 2 | 1811263 | Laser Notice No.56 |
| TD1 | CLASS 1 | 1810782 | Laser Notice No.56 |
Non-Contact Thermometers
| Series | Laser CLASS＊1 | Accession Number | FDA technical standards |
|---|---|---|---|
| BA*4 | CLASS 2 | 1811353 | Laser Notice No.50 |
| BS-02T | CLASS 2 | 1811350 | Laser Notice No.56 |
| CS-LDP | CLASS 2 | 1811351 | Laser Notice No.56 |
| PT-2LD*3 *4 | CLASS 2 | 1810649 | Laser Notice No.50 |
| PT-5LD/PT-7LD | CLASS 2 | 1810650 | Laser Notice No.56 |
| PT-S80/U80 | CLASS 2 | 1810651 | Laser Notice No.56 |
| TI-S | CLASS 2 | 2311228 | Laser Notice No.56 |
- *1.Laser class classification is based on IEC 60825-1:2014.
- *2.Only for models ending (E). (Excluding BGS-DL70x)
- *3.Only for models ending in "#".
- *4.Discontinued product.
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