Robin's Egg Laser Comb
by Telebrands Corporation 510(k)
Active
510(k) K240689
Overview
The Robin's Egg is a Laser Comb for Hair, a Class II medical device designed for non-invasive hair removal. It combines laser technology with a handheld comb mechanism to target hair follicles, promoting hair reduction through controlled energy delivery to the scalp.
Supplied as a reusable device, the Robin's Egg is intended for use in clinical settings such as physical medicine offices. It operates under FDA 510(k) clearance (K240689) and adheres to 21 CFR 890.5500 for infrared lamp-based devices. No specific sterility or MRI safety information is provided in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240689 | Date17 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Robin's Egg
- 510(k) Number
- FDA Product Code
- OAP
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Telebrands Corp.
Questions
What is the primary use case for the Robin's Egg Laser Comb in clinical settings?
The Robin's Egg is designed for non-invasive hair removal, specifically targeting hair follicles on the scalp to promote hair reduction. It is intended for use in clinical settings like physical medicine offices, where controlled laser energy is applied through a handheld comb mechanism.
Is the Robin's Egg a single-use device or reusable, and how does this affect its maintenance?
The Robin's Egg is explicitly described as a reusable device, meaning it is not disposable. Since it is intended for clinical use, proper cleaning and maintenance protocols must be followed to ensure safety and efficacy between patient sessions. The manufacturer’s instructions should be consulted for specific care guidelines.
Are there any specific storage requirements for the Robin's Egg, particularly regarding environmental conditions?
The provided regulatory data does not explicitly detail storage requirements for the Robin's Egg. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. Always follow the manufacturer’s guidelines for optimal longevity and performance.
What regulatory pathway was followed for the approval of the Robin's Egg, and what does this imply for its use?
The Robin's Egg received FDA 510(k) clearance (K240689) under the traditional review pathway, classified as substantially equivalent to a predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II medical device, specifically under 21 CFR 890.5500 for infrared lamp-based devices. Clinicians may rely on this approval for its intended use in physical medicine settings.
Does the Robin's Egg have any known compatibility or safety concerns with MRI machines?
The regulatory data for the Robin's Egg does not mention MRI safety information, meaning its compatibility with MRI environments is not explicitly addressed. Clinicians should assume it may contain metallic or electronic components that could pose risks in an MRI setting unless verified otherwise by the manufacturer. Always consult the device’s documentation or manufacturer before using it near MRI equipment.