K Number
K121920
Device Name
LASERBRUSH
Date Cleared
2013-06-27

(360 days)

Product Code
Regulation Number
890.5500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.
Device Description
The Sunetics LaserBrush consists of a handheld low-level laser device intended to promote hair growth. Depending upon the Sunetics LaserBrush model, the device provides distributed laser light using seven (7), nine (9), or twelve (12), collimated, 650 nm, <5 mW laser modules, while brush bristles simultaneously part the user's hair to ensure that the laser light reaches the user's scalp.
More Information

Not Found

No
The document describes a low-level laser device for hair growth and does not mention any AI or ML components or functionalities.

Yes
The device is indicated to treat Androgenetic Alopecia, promote hair growth, and prevent further hair loss, which are therapeutic actions.

No

Explanation: The device is described as a low-level laser device intended to promote hair growth and treat hair loss, which is a therapeutic function, not a diagnostic one. Its intended use is for treating a condition, not identifying or analyzing it.

No

The device description explicitly states it "consists of a handheld low-level laser device" and details hardware components like laser modules and brush bristles. This indicates it is a physical device, not software only.

Based on the provided information, the Sunetics LaserBrush is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • The Sunetics LaserBrush is a physical device that applies low-level laser light directly to the scalp. Its intended use is to treat hair loss and promote hair growth, which is a therapeutic application, not a diagnostic one based on analyzing biological samples.

The description clearly indicates it's a handheld laser device for direct application to the scalp, not for analyzing biological specimens.

N/A

Intended Use / Indications for Use

The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.

Product codes

OAP

Device Description

The Sunetics LaserBrush consists of a handheld low-level laser device intended to promote hair growth. Depending upon the Sunetics LaserBrush model, the device provides distributed laser light using seven (7), nine (9), or twelve (12), collimated, 650 nm,

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

0

K121920

Sunetics International Marketing Group LLC

510(k) Submission Sunetics LaserBrush

ATTACHMENT 2

510(k) SUMMARY

JUN 2 7 2013

| 510(k) Owner: | Sunetics International Marketing Group LLC
892 Steger Towne Rd Suite # 44
Rockwall, TX 75032
Contact:
John Carullo
Phone:
214-683-0724 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Date Summary
Prepared: | June 21, 2012 | |
| Device: | Trade Name: | Sunetics LaserBrush |
| | Common/Classification Name: | Laser, Comb, Hair
Product Code OAP |
| | | 21 C.F.R. § 890.5500 (Infrared lamp) |
| | Classification: | Class II |
| Predicate
Device: | HairMax LaserCombs - models: Advanced 7, Lux 9, Professional 12
Lexington International, LLC
K110233, K103368, Κ112524 | |
| Device
Description: | The Sunetics LaserBrush consists of a handheld low-level laser device
intended to promote hair growth. Depending upon the Sunetics LaserBrush
model, the device provides distributed laser light using seven (7), nine (9), or
twelve (12), collimated, 650 nm,