Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.: 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. Its amount of 59 is below the median of 138 (16th percentile). Dated 27 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 59 · 16th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262834 |
| Device | Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) |
| Applicant | Shenzhen Jianchao Intelligent Technology Co., Ltd. |
| Specialty / panel | Other |
| Product code | OAP |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-11 |
| Decision date | 2026-10-09 |
| Review time (days) | 59 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |
| amount percentile | 16th of 414 (median 138, 0.4x median) |
| Peer records CSV (76 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-09
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.'s amount: 16th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 59-day review: this device is a strong predicate for similar products.
- Posted 27 days ago.
What is the FDAPulse record for Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.?
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834) by Shenzhen Jianchao Intelligent Technology Co., Ltd. was cleared on 2026-10-09 after 59 days of review.
How does Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. compare to other FDAPulse records?
Its amount of 59 is below the median (16th percentile); smaller records often move faster and face less competition. It is 27 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834) | CN | 2026-10-09 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) | CN | 2026-10-14 |
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How to monitor Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. and peer other records
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