LaserCap LC Pro and LC Elite

Q: What is the product code of K150613?

The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.

FDA 510(k) K150613 · Transdermal Cap, Inc.

Substantially Equivalent

510(k) numberK150613

Submission

Device name: LaserCap LC Pro and LC Elite
Applicant: Transdermal Cap, Inc.
Cleveland, OH, US
Received: March 10, 2015
Decision date: July 22, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OAP – Laser, Comb, Hair
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.5500
Specialty: Physical Medicine

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

Other 510(k)s with product code OAP

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K261253	Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…OAP · Traditional	Ziree Co., Ltd.	06/26/2026SE
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K253231	Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…OAP · Traditional	Hubei Yjt Technology Co.,Ltd	06/16/2026SE
K251684	Alma TED+ SystemOAP · Traditional	Alma Lasers, Inc.	06/05/2026SE
K253669	Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional	Shenzhen Kaiyan Medical Equipment Co., Ltd.	01/23/2026SE
K253349	Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional	Light Tree Ventures Europe B.V.	12/24/2025SE
K252414	Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional	Shenzhen Kaiyan Medical Equipment Co., Ltd.	10/30/2025SE
K252325	Hair Growth Laser CapOAP · Traditional	Cosmo Far East Technology Limited	10/22/2025SE
K251017	CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP · Traditional	Shenzhen Kaiyan Medical Equipment Co., Ltd.	06/17/2025SE

More from Shenzhen Kaiyan Medical Equipment Co., Ltd.

510(k)	Device	Decision
K203826	LaserCap Family of Lasers 300, 224, 120 & 80OAP · Traditional	03/29/2021SE
K161875	LaserCap300, LaserCap224, LaserCap120, LaserCap80OAP · Traditional	09/30/2016SE

Questions and answers

When was LaserCap LC Pro and LC Elite cleared by the FDA?

LaserCap LC Pro and LC Elite (K150613) received a 510(k) decision of Substantially Equivalent on July 22, 2015, 134 days after the submission was received.

What is the product code of K150613?

The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.