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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 October 21, 2014 Erchonia.

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The FDA has the authority to regulate all kinds of lasers. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the agency regulates lasers used in medicine.

Erchonia's Emerald laser is an FDA Market-Cleared full body fat loss treatment that allows clients to target areas of stubborn fat. Emerald Laser treats overall body circumference and is the only device FDA cleared to treat those with a BMI up to 40.

List of FDA-Approved Lasers for LASIK Device NameCompanyLADARVision Excimer Laser SystemSummit Automonous, Inc.Nidek EC-5000 Excimer Laser SystemNidek Technologies, IncTECHNOLAS 217A Excimer Laser SystemTECHNOLAS GMBH Perfect VisionVISX Excimer Laser System Model C “Star”AMO Manufacturing USA, LLC31 more rows

Let's be super clear: There is no limit on the strongest laser you can legally own in the United States. However, under federal law as governed by the FDA, any laser above 5 mW must comply with FDA/CDRH laser product requirements for labels, safety features, quality control and more.

Any laser demonstrations, displays or shows that use lasers above 5 milliwatts must have a “variance” from FDA. This document gives the variance holder permission to “vary” from the 5 milliwatt limit, by using more power.

FDA Approval: What it means. FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

The FDA regulates both medical and non-medical lasers. The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232