Cosmo Laser - Professional Laser Machine Manufacturer for Various Industries
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Cosmo Laser - Professional Laser Machine Manufacturer for Various Industries
The FDA regulates laser machines in the United States to protect public health and ensure safety standards are met. The FDA regulates both medical and non-medical lasers.
Why the FDA regulates lasers:
1. Safety: Lasers can pose significant risks, including flash blindness, injury, and other potential harm.
2. Compliance: The FDA ensures that manufacturers comply with safety guidelines and federal standards.
3. Recalls: The FDA may require recalls for products that don't meet federal standards or have radiation safety defects.
FDA laser regulations:
* The FDA's Center for Devices and Radiological Health (CDRH) oversees the regulation of laser products.
* The FDA may issue variances to allow manufacturers to vary from federal regulations.
* Manufacturers and importers of laser products must affix a label to the product that declares compliance with applicable standards.
- FDA Information of COSMO LASER EQUIPMENTS -
Certification of FDA Registration
This certifies that:
COSMO LASER EQUIPMENTS
No.27/1, 4th Floor, Sha Du Road, Fu Chong Village, Sha Wan Town, Panyu District, Guangzhou, Guangdong province, China 511483
has been filed according to reporting requirements in Title 21, Code of Federal Regulations (CFR), Part 1002. Submission has been assigned an informal subject title below after "Purpose:". Submission has been assigned an ACCESSION NUMBER which can be used by you and FDA to identify submission
Accession Number: 2510323-000
Establishment Name: COSMO LASER EQUIPMENTS
Purpose: This submission is a(n) Initial Product Report. These Material Processing Laser Products include designated model(s) Sparrow60E, CTM-20L, CTM-70L, CUV-15, Sparrow60EC, Sparrow30EC, CTM-100L, CCO-100, CCO-60, Sparrow20E, CTM-20m, CTM-50L, Sparrow30, CTM-80L, CTM-60L, CTM-30L, Sparrow30E, Sparrow20EC, CM-20, CTM-GL70, CTM-GL60, CTM-GL50, CTM-GL20, CCO-30, CUV-20, CUV-10, CTM-GL100, CTM-GL80, CTM-GL30, Sparrow60, Sparrow20, CUV-5, CTM-50m, CAM-MARK.
This certificate affirms that the above stated facility is registered with the U.S. Food and Drug Administration pursuant to Title 21, Code of Federal Regulations (CFR), Part 1002, such submission having been verified as effective by OUA as of the date hereof, and OUA will confirm that such registration remains effective upon request and presentation of this certificate until and expiration of one year from the date hereof, unless terminated after issuance of this certificate. OUA makes no other presentations or warranties, nor does this certificate make any representations or warranties to any person or entity other than the names certificate holder, for whose sole benefit it is issued. OUA assume no liability to any person or entity in connection with foregoing.
- INSTRUCTIONS TO IMPORTERS/BROKERS OF ELECTRONIC PRODUCTS -
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PURPOSE: The Form FDA 2877 must be completed for electronic products subject to Radiation Control Standards (21 CFR 1010 and 1020-1050) prior to entry into the United States. The local Food and Drug Administration (FDA) district office will review the declaration and notify the importer/agent if the products may be released into U.S. commerce or if they must be held under bond until exported, destroyed, or reconditioned. Until the shipment is released, it may be subject to redelivery for FDA examination.
PAPER OR ELECTRONIC SUBMISSION: Paper entries may be made by submitting the signed original FDA 2877 along with U.S. Customs forms to the local FDA district office; if electronic products are given a MAY PROCEED, a signed copy of CF 3461 will be returned, or if not given a MAY PROCEED, a FDA Notice of Action will be issued. For electronic entries, follow U.S. Customs Service ACS/ABI format and procedures, supported by a signed copy of this form or similar letter. Multiple entries of the same product and model families that are filed electronically may be supported by one form dated not more than 12 months previously.
DECLARATION: Select A, B, C, or D and then select the appropriate number; fill in requested information and sign. For electronic entries, AofC (affirmation of compliance) = RA#, RB#, RC#, or RD# (e.g., Radiation Declaration A5 = RA5). Transmit model number using AofC code MDL and transmit brand name using FDA line level brand name field. If RA3 or RA6 is selected, you must transmit quantity (number of units) using the Quantity and Unit of Measure Pairs at the FDA line level.
DECLARATION A: Importers should be prepared to demonstrate compliance to or non-applicability of FDA standards, regulations, or guidance. Components or sub-assemblies must be non-functioning. Products being reprocessed must be exported by the importer, without intermediate transfer of ownership. For RA3 the quantity is 3 units. For RA6 the limit is 50 microwave ovens and Class 1 laser products limit is 200 units for optical drives, such as CD/DVD laser products. See May 14, 1997, notice to industry issued by the Center for Devices and Radiological Health (CDRH).
DECLARATION B: If declaration RB1 is selected, provide the FDA Establishment Identifier (FEI) of the manufacturer who filed the radiation product/abbreviated report to FDA, CDRH. To transmit the accession number of that report use AofC code ACC. If the manufacturer cannot be determined or located, the importer must be able to provide evidence showing a certification label on each product and state reason: returned to original exporter or certification label evidence. Providing a photo showing the manufacturer's label carrying the certification statement is strongly recommended.
DECLARATION C: Noncompliant products may be imported only for research, investigations/studies, demonstration or training. They should be used only by trained personnel and under controlled conditions to avoid unnecessary radiation exposure. Product(s) will be detained by the local FDA district office. Since product(s) for which "C" Declarations are made will be under Temporary Import Bond (TIB) or equivalent, ultimate disposition is limited to export or destruction under U.S. Customs supervision when the purpose has been achieved or the length of time stated has expired. For purposes other than demonstration, the Form FDA 766, outlining protections, must be approved by FDA prior to use. The importer/broker must include with the FDA 766:
1. A full description of the subject electronic product(s).
2. The purpose for which the product(s) is being imported.
3. How the product(s) will be used.
4. Where the product(s) will be located.
5. The approximate length of time and dates the product(s) will be in this country.
For product(s) being used for trade shows/demonstrations, list the dates and use restrictions (Form FDA 766 is not required). A sign stating that the product does not comply with FDA performance standards must be displayed and viewable at all times during the use of product(s). All medical products, cabinet x-ray, or Class IIIb and IV lasers may NOT operate (turn on product(s)) at trade shows.
DECLARATION D: Noncompliant products must be brought into compliance with standards under FDA supervision and following a detailed plan approved by FDA. The plan, documented on the Form FDA 766, must address technical requirements, labeling, and reporting. Some plans may need approval by both the CDRH and the local FDA district office. Use of this declaration is limited to occasional shipments; ongoing reconditioning is considered manufacturing that is handled through other means. Product(s) will be detained by the local FDA district office. An FDA 766 must be filed indicating the procedure intended to bring the product into compliance. This procedure will include a satisfactory corrective action plan and/or a product report. The FDA 766 must include all of the information requested under Declaration C. The approximate length of time will be for the amount of time needed to bring product(s) into compliance. Declaration D is also made for failure to provide reports, failure to certify, etc.
If an importer/broker intends to import equipment into the United States for purposes of research, investigation, studies, demonstrations, or training but also wishes to retain the option of bringing the product into compliance with the performance standard, check Declarations C and D on the FDA 2877 and insert the word "or " between the Affirmations. Note: The U.S. Customs Service will treat this entry as a "D" Declaration for purposes of duty. Such requests must be made on the FDA 766; include Items 1, 2, and 3 under Declaration C, a statement of the need to use the option "C" or "D" Declaration, a statement of how the product(s) will be brought into compliance and the approximate length of time necessary to evaluate or demonstrate the product(s) and the time necessary to bring the product(s) into compliance (both actions must be accomplished within the period of time granted by FDA). For electronic entries select Declaration RD3.
Ultimately, product(s) must be brought into compliance with the applicable standard in accordance with a corrective action plan which has been approved by the FDA. If the product(s) are not brought into compliance within the allotted time frame of the approved application and an extension is not requested of, or granted by, the FDA, the local FDA district office shall refuse entry on the shipment and require the product(s) to be either exported or destroyed under U.S. Customs supervision.
If additional guidance is needed, please contact your local FDA district office or consult the following FDA web pages: https://www.fda.gov/radiation-emitting-products/getting-radiation-emitting-product-market-frequently-asked-questions/importing-and-exporting-electronic-products and https://www.fda.gov/industry/import-program
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