Author Topic: FDA regulations--do these lasers meet them?  (Read 1153 times)


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FDA regulations--do these lasers meet them?
« on: June 25, 2017, 01:24:41 AM »
According to 21 CFR 1040, a class IV laser such as these requires a bunch of safety equipment such as a key switch and a safety interlock dongle that this machine simply doesn't have.  Is everything on the up and up with these machines?


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Re: FDA regulations--do these lasers meet them?
« Reply #1 on: June 25, 2017, 04:11:08 AM »
There is a lot on SEARCH IN THIS FORUM about safety.  GOOGLES  or glasses...Enclosures.....OPERATION
These machines need SAFETY GLASSES  not only to protect you but other people who view the thing when operating.
As they come they can be considered dangerous to use without precautions. They need very good ventilation as some materials are pretty nasty when cut with a laser

 If you value your eyes then Google LASER SAFETY.  They are not toys but serious kit that can blind you in a fraction of a second.

The above refers to ALL  makes of lasers but we generally use the open frame types  (ex Banggood and others)...and then enclose them ourselves.
« Last Edit: June 25, 2017, 04:14:19 AM by ROSS »
Lasers are wonderful machines..not ONLY  can they cut a finger off BUT  they can also cauterise it at the same time.....



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Re: FDA regulations--do these lasers meet them?
« Reply #2 on: June 25, 2017, 04:19:11 AM »
You don't state what laser?

The 40W CO2 machine I have does indeed have a valid FDA/CE certificate, and includes key switches and interlock microswitches for all cabinet access. It also has a separate key on the EMO button to perform lock-out-tag-out (LOTO).

There is no radiation beyond the cabinet when in operation so meets all requirements.

The diode systems do not, obviously.
« Last Edit: June 25, 2017, 04:23:12 AM by Zax »


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Re: FDA regulations--do these lasers meet them?
« Reply #3 on: June 25, 2017, 04:58:47 AM »
It is a chinese company selling internationally, FDA rules apply to those assemblng or selling these devices within the US, so you are the one not complying as soon as you assemble it, they are not required to do anything as they sell a kit of parts.

So. reselling it fully assembled or publicly demstrating it is likely out, if you blind yourself, the only one to. blame is yourself for not following the regs.

I am in australia, so FDA does not sffect me, however there is no way you can power up a class 4 in public without precautions and approvals.

Edit: I forgot to mention, the FDA is a corrupt pack of morons who happily ignore evidenece to suit plolitical agendas and the money trail, so stuff em.

« Last Edit: June 25, 2017, 05:05:14 AM by Stonemull »
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