Question about FDA Classification of a Device

[dinaroxentool]

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!

 

[shimonv]

Yap, product code= OLP. Regulation number = 21 CFR 878.4810.

Have a look at K183708 and K183247 to boost your confidence

Good luck,
Shimon

 

[Pads38]

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]

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

 

[Parul Chansoria]

Please find the answers below,
#1 - Yes, it can be imported if there is no deviation of the device’s intended use w.r.t the identification per 21 CFR 890.5500. See 21 CFR 890.9 for terms and conditions of the exemption.
#2 - Yes, for performance standards you can comply with 21 CFR 1010.
#3 - As long as your product is strictly within the definition of ILY, Product and Annual reports per 21 CFR 1002 shall not be applicable.

 

[Ronen E]

Generally speaking, 21 CFR parts 1000-1050 might be applicable to all electrical / electronic products being considered for importation into the USA, and a careful review is required for determining which sections apply in any specific case. Where a device is within the scope of a specific section in these parts, compliance is mandatory.