Promulgated under the Securities Act of 1933, as amended. See Underwriting.Įstimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) Of common stock that the underwriters have the option to purchase. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodįor complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. See the definitions of large accelerated filer, accelerated filer smaller reporting company and emerging growth company in Rule 12b-2 of the Exchange Act: Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acceleratedįiler, a smaller reporting company or an emerging growth company. ☐Īmendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. Registration statement number of the earlier effective registration statement for the same offering. If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act The Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of (Name, address, including zip code, and telephone number, including area code, of registrants agent for service)Īpproximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective. (Address, including zip code, and telephone number, including area code, of registrants principal executive offices) (Exact name of registrant as specified in its charter) Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.As filed with the Securities and Exchange Commission on October 1, 2021 The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexicoġ A record in this database is created when a firm initiates a correction or removal action. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Distributors were asked to forward individual serial number packages to their customers. International packages were sent to each distributor via Fed-x/DHL tracking on. Candela services will contact the customers and schedule upgrades. Internal component may overheat causing the possibility of risk of fire or smokeĬandela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on. Class 2 Device Recall Candela Corporation Vbeam Aesthetica Laser SystemĬandela Corporation Vbeam Perfecta Laser System, Model/Catalog # 00 Vbeam Perfecta w/ gray enclosure and gray colored displayĩ914-0300-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model)
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |