Cleared Traditional

K251684 - Alma TED+ System

K251684 is an FDA 510(k) clearance for Alma TED+ System, manufactured by Alma Lasers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K251684 · Alma Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
368d
Days
Class 2
Risk

K251684 is an FDA 510(k) clearance for the Alma TED+ System. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Alma Lasers, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on June 5, 2026 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Alma Lasers, Inc. devices

FDA 510(k) Submission Details - K251684

510(k) Number K251684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2025
Decision Date June 05, 2026
Days to Decision 368 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 115d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAP Device Classification - Class 2, Special Controls

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAP Laser, Comb, Hair

All 108
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K251684.
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
K261253 · Ziree Co., Ltd. · Jun 2026
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
K253231 · Hubei Yjt Technology Co.,Ltd · Jun 2026
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
K260899 · Zdeer Technology (Henan) Co., Ltd. · Jun 2026
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)
K253669 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jan 2026
Hair Regrowth Cap (Model: T-119-HRC)
K253349 · Light Tree Ventures Europe B.V. · Dec 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Oct 2025