Florida Regulations 64E-4.001: Registration and Laser Radiation Requirements, Definitions, Exemptions, LSO, Out-of-State Sources, MPE, Safe Operation, Signs, Labels, Posting, Surveys, Measurement, Instrumentation, Notification, Reports, Incidents, Re…
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(1) Except as otherwise specifically exempted under these rules, all persons who receive, possess, acquire, transfer, own, manufacture, or use lasers which emit or may emit laser radiation shall register within 30 days after acquisition of a laser product and comply with these rules. Nothing in these rules shall be interpreted as limiting the intentional exposure of patients to laser radiation for the purpose of treatment or use commensurate with the licensed practitioner’s use of the healing arts.
(2) A separate registration is required for each location with a laser device, on DH Form 1605 (09/14), “”Laser Device Registration Form,”” incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-04839, or www.FloridaHealth.gov/radiation. Laser manufacturers must register on DH Form 1604 (09/14), “”Manufacturer’s Laser Device Registration Form,”” incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-04838, or www.FloridaHealth.gov/radiation. Subsequent registrations for each facility or mobile laser facility are required whenever additional laser devices are installed or previously registered laser devices are disposed of, altered, destroyed or moved to new locations. Subsequent registrations for each manufacturer are required only when the description of the laser devices manufactured by the manufacturer changes.
(3)(a) Laser products certified by a manufacturer to be compliant with the Federal laser product performance standard of 21 C.F.R. part 1040 in effect at the date of manufacture shall be maintained in compliance with such requirements. Certified laser products which have been modified shall comply with these rules.
(b) Uncertified lasers shall meet the requirements of these rules.
(4) If any conflict arises between the requirements of these rules and the federal laser product performance standard, the requirements of the federal standard shall apply.
(5) Except as provided in this rule section, the contents of this rule chapter are contained in the Department of Health publication “”Laser Radiation Requirements,”” (December 15, 2016, edition), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07888.
(6) Title 21 C.F.R. § sections 1040.10 and 1040.11, (April 1, 2013, edition), are incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07889.
(7) The publication ANSI Z136.1-2014, “”American National Standard for Safe Use of Lasers”” (ANSI), is incorporated by reference and available at www.lia.org. This publication may be examined and inspected at the Florida Department of Health, Bureau of Radiation Control, 4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250. The agency has determined that posting the publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law.
(8) Completed registration forms or other correspondence or reports required by Fl. Admin. Code Chapter 64E-4, to be sent in writing to the Department can be mailed to Florida Department of Health, Bureau of Radiation Control, 4052 Bald Cypress Way, Bin #C-21, Tallahassee, Florida 32399-1741; faxed to (850)487-0435; or scanned and emailed to RadiationControl@FlHealth.gov in PDF, JPG or TIF format.
Rulemaking Authority Florida Statutes § 501.122(2). Law Implemented 501.122(2) FS. History-New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.101, Amended 4-20-15, 3-28-17.
(2) A separate registration is required for each location with a laser device, on DH Form 1605 (09/14), “”Laser Device Registration Form,”” incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-04839, or www.FloridaHealth.gov/radiation. Laser manufacturers must register on DH Form 1604 (09/14), “”Manufacturer’s Laser Device Registration Form,”” incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-04838, or www.FloridaHealth.gov/radiation. Subsequent registrations for each facility or mobile laser facility are required whenever additional laser devices are installed or previously registered laser devices are disposed of, altered, destroyed or moved to new locations. Subsequent registrations for each manufacturer are required only when the description of the laser devices manufactured by the manufacturer changes.
(3)(a) Laser products certified by a manufacturer to be compliant with the Federal laser product performance standard of 21 C.F.R. part 1040 in effect at the date of manufacture shall be maintained in compliance with such requirements. Certified laser products which have been modified shall comply with these rules.
(b) Uncertified lasers shall meet the requirements of these rules.
(4) If any conflict arises between the requirements of these rules and the federal laser product performance standard, the requirements of the federal standard shall apply.
(5) Except as provided in this rule section, the contents of this rule chapter are contained in the Department of Health publication “”Laser Radiation Requirements,”” (December 15, 2016, edition), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07888.
(6) Title 21 C.F.R. § sections 1040.10 and 1040.11, (April 1, 2013, edition), are incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07889.
(7) The publication ANSI Z136.1-2014, “”American National Standard for Safe Use of Lasers”” (ANSI), is incorporated by reference and available at www.lia.org. This publication may be examined and inspected at the Florida Department of Health, Bureau of Radiation Control, 4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250. The agency has determined that posting the publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law.
(8) Completed registration forms or other correspondence or reports required by Fl. Admin. Code Chapter 64E-4, to be sent in writing to the Department can be mailed to Florida Department of Health, Bureau of Radiation Control, 4052 Bald Cypress Way, Bin #C-21, Tallahassee, Florida 32399-1741; faxed to (850)487-0435; or scanned and emailed to RadiationControl@FlHealth.gov in PDF, JPG or TIF format.
Rulemaking Authority Florida Statutes § 501.122(2). Law Implemented 501.122(2) FS. History-New 9-6-84, Amended 5-7-96, 12-12-96, Formerly 10D-89.101, Amended 4-20-15, 3-28-17.