SBS - The Best Value in QMS software

Question about FDA Classification of a Device

#1
Hello everyone! I hope you are healthy and doing well!


I have a question about the classification of a device according to the FDA.


The product is an Over-The-Counter Powered LED Blue Light Therapy Device to treat Acne.


I searched in the "Access data" database (I cannot post links).


I searched for “acne” products and I clicked on “Over-The-Counter Powered Light Based Laser For Acne”


Finally, I get the following classification: 878.4810


TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES​

PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E--Surgical Devices

Sec. 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a) Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.
(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b) Classification. (1) Class II.
(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]



My question is: My product is a blue light-based device, but not a laser device. Is this the best classification I can get according to the FDA?


Thank you very much in advance!
 
Elsmar Forum Sponsor
#3
After a quick search I suggest the ProCode of OLP.
This specifically refers to OTC devices for acne treatment but it does still point to 878.4810 with seems to be specific to laser devices.
But as your device is NOT CO2 laser and NOT argon laser perhaps it fall into the third definition and is thus Class 1.

For a possible predicate see here:
510(k) Premarket Notification
 

duinyk

Involved In Discussions
#4
Hello, I have an imported Red Light therapy device which will classify under FDA code ILY Reg Number; 890.5500 which is currently a class II 510k exempt and says performance standards. However, I cant find any specific performance standards for REd light therapy devices.

1. Does this mean I my regulatory strategy can involve just meeting all regulatory controls and proceeding with establishment registration and device listing and then importation requirements?

2. Since, I cant find performance standards for red light therapy can I go with a 21 CFR 1010 PART 1010 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL?

3. Are red light therapies subjected to Product or Annual reports under 21 CFR 1002 or only to the general requirements in Title 21 CFR 1000 through 1005?

Any insight will be very welcomed and helpful.

Thanks
 
Thread starter Similar threads Forum Replies Date
P FDA's DRLM (Device Registration & Listing Module) Listing Number Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
Q US FDA UDI Compliance Question - Class II (Special Controls) Other Medical Device and Orthopedic Related Topics 4
A Question about what FDA looks for in equipment validation US Food and Drug Administration (FDA) 3
Z Re-packager/Re-Labeler - FDA Registration question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R ISO 13485 vs FDA Requirement question about when ISO 13485 Certification is Required ISO 13485:2016 - Medical Device Quality Management Systems 4
S Question on Device Listing for a FDA registered facility US Food and Drug Administration (FDA) 6
S FDA Facility Establishment Identifier (FEI) question US Food and Drug Administration (FDA) 7
D Question... Record retention Prior to FDA NDA application and approval Records and Data - Quality, Legal and Other Evidence 3
A Question about FDA 21 CFR Part 820.90 Nonconforming Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S FDA Device Listing Question - "Each Device" Definition - 21 CFR Part 807 Other US Medical Device Regulations 4
Q FDA's jurisdiction over Non-Research Medical Clinics - Question US Food and Drug Administration (FDA) 2
A FDA product Labeling Question - Re-selling and Re-labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M question on FDA and Health Canada US Food and Drug Administration (FDA) 1
D FDA Question: Contents of an FDA 510(k) Submission ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 0
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Configuration Item definition question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Quality Management System Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 10
J IATF 16949 Calibration/Verification records question ISO 26262 - Road vehicles – Functional safety 5
I IMDS Error Message Question RoHS, REACH, ELV, IMDS and Restricted Substances 1
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 3
C Gauge R&R Question Using Minitab Software 1
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
K Question on MDR classification EU Medical Device Regulations 4
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 6
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8

Similar threads

Top Bottom