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510(k) K240689

Robin's Egg by Telebrands Corporation — Product Code OAP

K240689 is an FDA 510(k) premarket notification submitted by Telebrands Corporation for the device "Robin's Egg". The FDA issued a decision of Substantially Equivalent on September 17, 2024. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2024
Date Received
March 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Comb, Hair
Device Class
Class II
Regulation Number
890.5500
Review Panel
SU
Submission Type

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

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  • K261253 — Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H (June 26, 2026)
  • K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Las (June 16, 2026)
  • K260899 — Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157 (June 16, 2026)
  • K251684 — Alma TED+ System (June 5, 2026)
  • K253669 — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (January 23, 2026)
  • K253349 — Hair Regrowth Cap (Model: T-119-HRC) (December 24, 2025)
  • K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (October 30, 2025)
  • K252325 — Hair Growth Laser Cap (October 22, 2025)
  • K251017 — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (June 17, 2025)

FDA data resources